Distributed to the following states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, , WA, WV, WI, and Washington, D.C.  And PR
Phenylephrine HCL (0.1%) 1mg/mL Injectable  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.     Known lot codes: 07202016@44
Cyclosporine (A) Oil Solution, 10 ML, 2% ML Opthalmic.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes: 071402016@35, and 08022016@20
Pentosan Sodium Polysulfate 250MG/ML Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes #'s: 03252016@33, 05112016@8, and 06142016@47
Estradiol Cypionate 5MG/ML, Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot code: 05092016@12
Flunixin Meglumine, 100 ML vial, 50MG.ML, Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes:  08112016@7
Estrone Aqueous - 5 MG/ML, 50 ML vial, Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes: 06272016@29 and 08022016@8
Medroxyprogesterone Acetate 200 MG/ML Injectable.  Compounded by Wells Pharmacy
Histrelin Acetate, Lyophilized Kit 5.5MG Kit, Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot code: 05022016@110
Methocarbamol 100 MG/ML, Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes: 05272016@3, and 0622016@7
Detomidine HCL/Xylazine - 10MG/10MG/ML (20MG Vial) Injectable.  Compounded by Wells Pharmacy
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.   Known lot codes: 04272016@94, 0and 8022016@70
Progesterone in Sesame Oil 150MG/ML Injectable.  Compounded by Wells Pharmacy
Worldwide distribution.  The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY.    The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Durex Pleasure Pack .  3 ultra fine lubricated latex condoms  12 ultra fine lubricated latex condoms   24 Ra fine lubricated latex condoms         3 ct  UPC 3-02340-30042-04-1  3 ct - Walmart UPC 02340-70042-04  12ct - UPC 3-02340-30274-08-6  24 ct - UPC 302340-302190-04    (contacting firm for label)
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
3ct - item code 02340-30042-04    lot code exp date     3 ct - Walmart item code 02340-70042-04    lot code exp date     12ct - item code 02340-30274-08    lot code exp date     24 ct - item code 02340-302190-04    lot codes and exp date
Distribution was nationwide to medical facilities.  There was also government and foreign distribution, including Canada.
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS.  The firm name on the labeling is Merge Healthcare, Hartland, WI.
1,627 sites potentially have the affected versions
due to an issue when validating patients using only an Medical Record Number (MRN)
Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3;  Merge Eye Station: All versions;  Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
Product distributed to grocery stores and grocery store distribution centers in AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY
Palmer's Candies Cookies & Cream Bark, NET WT 9 OZ (255 g) packaged in plastic clamshell container, UPC Code 77232-17254
Product contains an ingredient that was recalled by a supplier because it may be contaminated with Salmonella
Palmer's Candies Game Day Party Bowl NET WT 16 OZ (454 g) packaged in plastic containers, UPC Code 77232-17291
Palmer's Candies Chocolatey Tree Pretzels NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10799
Palmer's Candies Chocolatey Pretzels NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10798
Palmer's Candies Christmas Tree Pretzel, NET WT 7 OZ (198 g) packaged in plastic clamshell container, UPC Code A) 77232-16310 and B) 77232-17137
A) 97/8/7 OZ/clamshells/cases B) 1237/16/7 OZ/clamshells/cases
Palmer's Candies Bakery Delights Christmas Tree Pretzels NET WT 5 OZ (141 g) packaged in foil bags, UPC Code 77232-13227
Palmer's Candies Chocolate Pastel NP Pretzels NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10783
Palmer's Candies Creme De Menthe Bark, A) NET WT 9 OZ (255 g) packaged in cardboard boxes, UPC Code 77232-16043, B) NET WT 9 OZ (255 g) packaged in plastic clamshell containers, UPS code 77232-17255; C) NET WT 10 lbs Net Weight (4.54 kg) packaged in cardboard boxes
A) 1/12/9 OZ/boxes/cases B) 99/16/9 OZ/clamshells/cases and 125/32/8 OZ/clamshells/cases, C) 261 cases
A) Peppermint Pretzels NET WT 5 OZ (141 g), packaged in foil bags, UPC 25439-20204; B) Mix Peppermint Pretzels NET WT 7 OZ, UPC 77232-12147
Palmer's Candies Chocolatey Football Pretzels NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10880
Palmer's Candies Swirled Pretzels NET WT 5 OZ (141 g) packaged in foil bags, UPC Code 77232-13990
Trail's End Gourmet Chocolatey Crunch A) NET WT 18 OZ (1.13 LB) 510 g, packaged in foil bags; B) NET WT 15 OZ packaged in foil bags;
Palmer's Candies Chocolate Pretzels with Frosted Swirl NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10743
Palmer's Candies Drizzled Peanuts Brittle A) NET WT 8 OZ (226 g) packaged in plastic clamshell containers, UPC  77232-17002; B) 20 lbs. Net Weight (9.07 kg) packaged in cardboard boxes UPC 77232-10809
A) 1,280/24/8 OZ/clamshells/cases and 131/16/8 OZ clamshells/cases; B) 217 cases
Palmer's Candies A) Holiday Treats NET WT 15.5 OZ (439 g) packaged in plastic containers, UPC Code 77232-23045; B) Holiday Gift Bowl NET WT 22 OZ (623 g) packaged in plastic containers, UPC 77232-17285; C) Variety Christmas Bowl NET WT 15 OZ (425 g), packaged in plastic containers, UPC 77232-02580
Palmer's Candies Peppermint Bark A) NET WT 9 OZ (255 g) packaged in plastic clamshell containers, UPC Code 77232-17270; B) NET WT 10 OZ (283 g) packaged in paper bags, UPC 77232-23091; C) NET WT 8 OZ (226 g) packaged in paper boxes UPC 77232-12146; C) NET WT 9 OZ (255 g) packaged in plastic clamshell containers UPC 77232-16309; D) NET WT 9 OZ (255 g) packaged in paper boxes UPC 77232-16042; E) 10 lbs. Net Weight (4.54 kg) packaged in cardboard boxes UPC 77232-10770
A) 3,675/16/9 OZ/clamshells/cases, B) 1,141/18/10 OZ/bags/cases, C) 7,538/24/8 OZ/boxes/cases D) 1/12/9 OZ/boxes/cases E) 1,021 cases
A) Palmer's Candies Chocolate Almond Bark , NET WT 9 OZ (255 g) packaged in plastic clamshell container, UPC 77232-17250; B) Publix Bakery Almond Bark with Cocoa, NET WT 10 OZ (283 g), packaged in paper bags, UPC 77232-22691; C) Palmer's Candies Chocolate Almond Bark, 10 lbs. Net Weight (4.54 kg)
A) 1,909/16/9 OZ/clamshells/cases and 6/24/9 OZ/clamshells/cases; B) 2618/18/10 OZ/bags/cases; C) 613 cases
Palmer's Candies Chocolatey Flavored NP Heart Pretzels NET WT 28 lbs (12.7 kg), packaged cardboard boxes, UPC 77232-10778
US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.
Keyspan High-High Speed USB to Serial Adapter    Product Usage:  The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.
Power outages causes reporting software to shutdown.
All G8's with Reporting Software interfaced with LIS.
Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Oxford Knee System Tibial Resector Body Tube & Guides    Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Item: 32-423200, Lots: ZB160602  ZB160701, ZB160801, OXF TIB RESECT BODY TUBE & GD
Oxford Partial Knee System Right Medial Tibial Trial Tray Size D  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C     Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
Oxford Unicompartmental Knee Phase 3 Shim Size 2  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Unicompartmental Knee Phase 3 Shim Size 1  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Left Medial Tibial Trial Tray Size E  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size B  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A    Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Left Medial Tibial Trial Tray Size D  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Unicompartmental Knee Phase 3 Shim Size 3  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D    Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Femoral Slap Hammer  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Unicompartmental Knee Phase 3 Tibial Impactor  Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A    Product Usage:  Instruments for use with the Oxford Uni Partial Knee System
Nationwide.  There was no foreign/government/military distribution.
Holiday White Peppermint Hostess Twinkies, cream-filled snack cakes, Net Wt. 13.02 oz. (369 g), UPC 888109111571.
Product contains an ingredient that was recalled by a supplier because it may be contaminated with Salmonella.
Vascular catheter introduction kit  The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
There have been complaints for peel away sheaths flaring
Recalle products were distributed only to Hy-Vee retail stores in the following states: KS, IA, IL, MN, MO, NE, SD, and WI.
Dazzled Peanut Brittle packaged in 8oz. (UPC 026267300000) and 12 oz. (UPC 026267400000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
Sell by date range:  January 26 - February 23, 2017.
/48 oz. (UPC 026138200000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
Chocolate almond pretzels packaged in 4 oz. (UPC 026131900000) and 12 oz. (UPC 026131800000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
Peppermint Bark packaged in 4oz. (UPC 026133800000),12 oz. (UPC 026133700000) plastic tray containers, and 9 oz. tubs (UPC 026267900000) for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
Chocolate almond bark packaged in 4 oz. (UPC 026133400000) and 12 oz. (UPC 021633300000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
/48 oz. (UPC 026138800000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
/64 oz. (UPC 026139700000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA.
AL, AR, FL, GA, IN, KY, LA, MO,  MS, NC, SC, TN, TX, VA
Golden Flake (R) HOT THIN & CRISPY POTATO CHIPS, NET WT. 5 OZ. (141.8g), Golden Flake Snack Foods, Inc., Birmingham, AL  35201, UPC 0-72080-00240-3
Lot Numbers:  APR1417 364 5 and APR1417 365 5
Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD     Product  Usage:  In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values.  The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
US Distribution to the states of : AZ, CA, CO, CT, FL, GA, ID, LA, ME, MO, MN, NC, OH, OK, OR, TN, TX, UT, WA, and WI., and to the United Kingdom.
AMT 12 inch Right Angle Feeding Set with Y-Port    Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Expired expiration dates are listed on the pouches.
AMT Bridle - Nasal Tube Retaining System    Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Philips Electronics North  America Corporation
Worldwide distribution including     Austria  Bangladesh  Bulgaria  Chile  France  Germany  Hong Kong  India  Ireland  Israel  Italy  Korea, Republic of  Malaysia  Myanmar  Philippines  Poland  Portugal  Saudi Arabia  Thailand  Turkey  United Arab Emirates  United Kingdom  United Republic of Tanzania
Philips Efficia CMS200 Central Monitoring System; 863352  The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals
156 devices, there is no US distribution
The monitor may not alarm appropriately for a pediatric or neonatal patient.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Sterility of syringe product could not be assured.
Trader Joe's Harvest Whole Wheat Bread;  NET WT 24 oz. (1 lb. 8 oz.)  SKU 00132;  UPC: 0000 1328.    Distributed and sold exclusively by:  Trader Joe's, Monrovia, CA 91016
Certain production dates of Trader Joe's Harvest Whole Wheat Bread do not declare cultured whey or list milk as an allergen.
Specialty Commodities, Inc., Almond, Dry RNS, SKU 0020034064 Item number ALMO-033, 25 lb carton.
One lot of dry roasted almonds may contain undeclared cashews.
Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway,  Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore,  Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305    ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
Potential performance issues.  False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
Sunmba Frozen Ajiaco (Vegetable Mix), 2 lbs.
Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Influenza Transport Swab Packages, Reference #20171,  One lot with 1010 packages (each package contains 25 transport tubes).    The Influenza Swabs in dry transport tubes are intended for use with influenza tests
Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
The product was distributed domestically and also to foreign consignees.  But not to government agency's or Canada.
Stabilizer Attachment and Titan TM  360 Stabilizer  Attachment
360 Stabilizers because the Suction Tubing Clip may break when it  is being attached to a Terumo CVS Hercules Stabilizing Arm.  Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.
Stabilizer Attachment , Lot Number: 052R      Catalog Number 401-231u , Product Description TitanTM  360 Stabilizer  Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R,  040 , 048R
Nationwide Distribution to LA, MS, SC, TX
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145  Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs    The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.  The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).  The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.    The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.
SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Nationwide to Colorado, New Mexico, Utah, and Nebraska. No Canadian, other foreign, or VA/gov/military consignees.
Falafel King Tzatziki Sauce. 10 ounce. Plastic container
Falafel King announced a recall for their Tzatziki Sauce due to undeclared milk on product label.
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide.     Product Usage:  The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that  have a shelf life shorter than the kit expiration date.
Soureliette cheese, Net Wt 3.969 lb (case)/ Net Wt 1.323 lb per unit,  Item number 707116
Tomme Brebis Fedou, Net Wt. 9.7lb (case)/Net Wt 4.85 lb per unit, Item number 702084
Product number: Art.-Nr. 702084MHD 22.02.2017
Jackson-Pratt  Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx   Distributed by Cardinal  Health,  USA  Catalog Number: JP-2187    For wound drainage.
Product sterility compromised due to breach of sterile barrier
Lot Number: P1546816  Expiration date: January 2021
Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
The Sarns Centrifugal Pump is a single use device  sterilized by ethylene oxide gas.  The device  is sold single sterile in cartons  of 8 units, or may be provided in bulk, non-sterile to another Terumo location  for inclusion in Cardiovascular Procedure Kits.   Cardiovascular Procedure kits are packaged individually.
579 units have entered into the distribution chain
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures.    In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks.    Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
Wegmans Organic Dark Red Kidney Beans, Net Wt. 15 OZ
Damaged cans could possibly cause a fracture and cause post process contamination.
Blood products, collected from a donor for whom eligibility to donate was incorrectly performed, were distributed.
Blood and Blood Products for Reprocessing
American National Red Cross (The) - North Central Region
Platelet products, for which  WBC quality control testing was not performed, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Michigan, Illinois, New York, Florida, Pennsylvania .
MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube,  Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35
MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E,  Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28
Nationwide  Foreign:  Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru,   Singapore, Venezuela
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
The single use devices are provided sterile and do not have an expiration date on the label.
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
Product distributed throughout United States
Nature's Wonderland Sinus & Lung Care, 60 VCaps (Capsules), PET bottle
There was a mix-up with ingredients used.  The product is an herbal blend consisting of 7 different herbs.  The blend calls for Ginger Root; however, Ginkgo Leaves was accidentally added.
Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
(a) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 5 oz. (UPC 17400-10505)  (b) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 10 oz. (UPC 17400-10507)   (c) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 16 oz. (UPC 17400-10502)
Foreign Material (Metal) in pouched Rice Mixes
(a) Best By June 2018 362M620; Best By June 2018 363M620; Best By July 2018 004M720; Best By July 2018 005M720  (b) Best By July 2018 006M720; Best By July 2018 007M720; Best By July 2018 008M720; Best By July 2018 009M720; Best By July 2018 010M720; Best By July 2018 023M720; Best By July 2018 024M720; Best By July 2018 025M720  (c) Best By July 2018 014M720; Best By July 2018 017M720; Best By July 2018 018M720
Mahatma Broccoli & Cheese Rice; 4 oz. net weight (UPC 17400-10529); packed 12 units in each case (sold as individual retail units).  Shelf life is 18 months
o Best By July 2018 019M720   o Best By July 2018 020M720
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA  95688 for Sandoz Inc., Princeton, NJ  08540.
. The pouch containing the patch is labeled correctly.
Blood product, in which donor suitability was not adequately determined, was distributed.
Product was distributed to  a sold customer in FL.
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
630 pills (21 bottles x 30 pills per HDPE bottle)
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Lack of Sterility Assurance: customer report of leaking bag
Ogo (Seaweed) packaged in plastic bags.    Label contains the product name, date of shipment, weight of the order, toute number, order number and Distributed By True World Foods Portland LLC.
21 bags of random weight.  Total weight recalled 31.94
True World Foods Portland, LLC received, repackaged and distributed Ogo (seaweed) which was recalled from the raw material supplier of the Ogo (or Limu) because it  was harvested from the farm that has been linked to Salmonella illnesses in the state of Hawaii.
Apheresis products for which quality control procedures were not performed, were distributed.