Recalling Firm
ErgoSafe Products, LLC (DBA) Prism Medical
Central Texas Regional Blood & Tissue Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.
US Nationwide distribution including Puerto Rico
Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
This product was distributed nationwide. Product was distributed in Canada.
Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
Nationwide and Canada. No other foreign or VA/govt/military consignees.
Product was distributed to MT and NV; one VA consignee.
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I
US and Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Denmark, Dominican Rep., Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, Russian Fed. ,Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, United Arab Emir., Venezuela, Virgin Islands, W.Bank/Gaza Strip
US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
DISTRIBUTION CENTERS: OR, OH, CO, KY, AZ, WI, GA, KS. RETAIL STORES: AL, GA, SC, MI, OH, WV, IL, IN, KY, KS, MO, NE, CO, NM, UT, WY, AZ, AK, ID, OR and WA.
USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Nationwide distribution to: PA, KS, AR, GA, IN, ME, MO, WI, IN, FL, VA, OH, NY, TN, MI, KY, DE
US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg.
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Nationwide in the United States and Puerto Rico
Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
US: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, MD, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TX, VA, WA, WV, WY, WI. OUS: Canada
North Carolina; New York; Massachusetts; Georgia
US: CA, OR, AZ, WA, NV, NM, CO, UT, ID, TX, MA, NH, CT, VT, NY, NJ, KY, PA, DE, VA, MD, DC, TN, MI, OH, IN, IL, MO, MN, WI, NE, KS, IA, GA, AL, NC, SC, LA, FL.
Geographic areas of distribution: Maryland and Connecticut The firm sold product to 14 of direct account customers. All direct account customers were distributors, schools, prisons, and similar institutions.
Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution.

Product Description
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Gift Sets with Chocolate Pretzel Dippers
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Pharmanex ageLOC TR90 Protein Boost. Protein Powder. Net wt. 1.59 lbs (720g). 30 Servings. Natural Vanilla Flavor. Lactose, Gluten, & Soy Free. Plant Protein/Vegetarian.
A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
A-series lift - A625 Manual Part No. 324117. Prism Medical.
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
The UNI-CP System; Model Number: 330230SND.
Private Selection, Salted Caramel Chocolate Almond Pie, NET WT 34 OZ ( 2 LB 2 OZ) 963g, UPC 1111054021. Container: In a labeled pie dome and base. Pies are distributed frozen. Some stores sell refrigerated and some sell frozen.
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
McCormick & Co., Inc., Stubbs Barbecue. 18oz Best By Date of January 17, 2020.
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
CELL-DYN Ruby System: List Number: 08H6701; Device Listing No: D019897. Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Hass Avocado HA LB Signature Farms 15/4 60 1- USA Hass Avocado HA LTP S 60 1 Index Fresh- USA Hass Avocado HA RPCFB 10/4 70 1 Index Fresh- USA Hass Avocado HA LTP 32 2 So Good- USA
Hass Avocado 32 1 Index Fresh- USA Hass Avocado 36 1 Index Fresh- USA Hass Avocado 40 1 Index Fresh- USA Hass Avocado 48 1 Index Fresh- USA Hass Avocado 60 1 Index Fresh- USA Hass Avocado 70 1 Index Fresh- USA
Hass Avocado HA LTP S 40 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA Hass Avocado HA LTP S 70 1 Index Fresh- USA
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
Pharmanex Cholestin. Cholesterol Health. 60 Softgels.
Pharmanex Cortitrol. Cortisol Management. 60 Capsules
Pharmanex BioGinkgo. Mental Sharpness. 60 Tablets
DR Systems Unity PACS software, now known as Merge Unity PACS
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
Great Shake Plus Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
Great Shake Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Great Shake Fortified Nutrition, Soy Formula, Vanilla Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Great Shake Plus Fortified Nutrition, Soy Formula, Vanilla Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
Great Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Great Shake Plus Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL). Store Frozen.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood and Blood Products for Reprocessing
Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated
Trader Joes Imported English Authentic Lemon Curd, 10.5oz (300g), 24 jars/case
Grove Fresh Pasteurized Apple Juice from concentrate, 4-ounce cartons, 100 % Pure.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge PACS software. The firm name on the label is Merge Healthcare.
Fusia Asian Aspirations Szechuan Stir Fry; A delicious blend of premium vegetables with a savory sauce packed in a plastic bag: Sauce packet included. NET WT 21 oz. (1 lb 5 oz) 595 g
Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.

Product Quantity
total 133,330 units (50,046 units in the US)
17 sites potentially have the affected versions
9 sites potentially have the affected version
110 sites potentially have the affected versions
248 sites potentially have the affected versions
4089 cases of multi-pack product (6 pacakges of Szechuan per case)

Reason for Recall
The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
DHEA-S causes falsely elevated progesterone results.
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
The product is not labeled with an ingredient statement and therefore, does not declare the allergens, soy and wheat.
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.
Sterility compromised due to breach in sterile barrier
Nu Skin announces a voluntary field action for Pharmanex ageLOC TR90 Protein Boost due to an undeclared milk allergen.
During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
Salted Carmel Chocolate Almond Pie was mislabeled. The wrong ingredient label was used which did not listed two allergens, eggs and almonds.
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
McCormick & Co., Inc., has decided to initiated a voluntary recall of there Stubbs Sticky Sweet BBQ Sauce 18oz Bottle. Best By Date of January 17, 2020. Because of a glass bottle defect. The glass defect involves various thickness and defects that may result in chipped or missing glass.
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Abbott Laboratories has identified occurrences where the Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage. CAPA-ER387133 is still pending per completion of the investigation.
Index Fresh is recalling avocados because they may be contaminated with Listeria monocytogenes.
The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Nu Skin announces a voluntary field action for Pharmanex Cholestin due to undeclared allergen; soy.
Nu Skin announces a voluntary field action for Pharmanex Cortitrol due to undeclared allergen; soy.
Nu Skin announces a voluntary field action for Pharmanex BioGinkgo due to undeclared allergen; wheat.
Reports were missing demographic header information when they were faxed to referring physicians.
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
Apheresis products, collected from unsuitable donors due to a donor screening deviation, were distributed.
Blood products, in which donor suitability was not adequately determined, were distributed.
Apheresis product for which white blood cell count testing was not performed, was distributed.
Blood products, collected from unsuitable donors were distributed.
Blood product, in which donor deferral and/or donor incorrectly deleted from deferral list, was distributed.
was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
Trader Joe's Co. is recalling the Lemon Curd because it contains undeclared milk in the sub-ingredient of butter.
The firm received several customer complaints regarding foreign material in the product. The firm tested seven of the returned product units and found that they were positive for undeclared milk. The product has been recalled due to undeclared milk.
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
Product was tested and found positive for Listeria monocytogenes.
Presence of Foreign Substance: foreign material found in the bulk inventory.

Code Info
Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide
LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249
SMN: 10381181: L2KPW2 kit lot 453 L2KPW2 kit lot 454 L2KPW2 kit lot 455 L2KPW2 kit lot 456 L2KPW2 kit lot 457 L2KPW2 kit lot 458 L2KPW2 kit lot 459 L2KPW2 kit lot 460 L2KPW2 kit lot 462 L2KPW2 kit lot 463 L2KPW2 kit lot 464 L2KPW2 kit lot 465 L2KPW2 kit lot 467 L2KPW2 kit lot 468 L2KPW2 kit lot 470 L2KPW2 kit lot 471 L2KPW2 kit lot 472 L2KPW2 kit lot 474; SMN: 10381170: L2KPW6 kit lot 453 L2KPW6 kit lot 454 L2KPW6 kit lot 455 L2KPW6 kit lot 456 L2KPW6 kit lot 457 L2KPW6 kit lot 458 L2KPW6 kit lot 459 L2KPW6 kit lot 460 L2KPW6 kit lot 461 L2KPW6 kit lot 463 L2KPW6 kit lot 464 L2KPW6 kit lot 465 L2KPW6 kit lot 466 L2KPW6 kit lot 467 L2KPW6 kit lot 469 L2KPW6 kit lot 470 L2KPW6 kit lot 471 L2KPW6 kit lot 472 L2KPW6 kit lot 474
Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
All lots of lenses sold between 10/31/2013 to 10/31/2016
Version 9.0.9 and earlier using EchoIMS.
Lot Numbers Version 6.20A Cat. Number 442953