Recalling Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure
Blood Bank Of San Bernardino And Riverside Counties
New York Blood Center, Inc. dba HBVS Elmsford Donor Center
Blommer Chocolate Company of California, LLC

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

Distribution Pattern
Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom
USA (nationwide) distribution to the states of : AL, CA, KY, IL, KS, MN, NY, OH, TX, VA and WI. Distributed internationally to: Australia, Canada, China, England, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Singapore, South Africa, South Korea, Taiwan, Vietnam
Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
Product was distributed nationwide in the USA
Product was sent to the following states: MO & OK
Distributed domestically to Distributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam
US Distribution to the state of OR, and Internationally to Colombia.
Michigan, Ohio and Wisconsin in retail stores and through distributors.
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
US Distribution to states of: MI, GA, and OH.
Worldwide distribution, including US nationwide.
US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
Distributed to Coremark's 124 stores around the region (Nevada, Arizona, Idaho, Wyoming, Colorado, Nebraska, Utah).
USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.
Product distributed to customer in Iowa.

Product Description
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Red Blood Cells, Leukocytes Reduced
Blood and Blood Products for Reprocessing
BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
7oz Fruit and cheese Snacks - no brand. 1 unit per case
5/2.5oz Slice Apples w/ grapes bags in clamshell - Aunt Mid s brand. 6 units per case
9oz Mix (red/green) Slice Apples Container - Fresh-Pak brand. 1 unit per case
3lb Bag Dice Red Apples - no brand. 4 units per case
5/2.2oz Slice Apple Bags in clamshell - Aunt Mid s Michigan Apples brand. 6 units per case
9oz Slice Apples Container - Fresh-Pak brand. 1 unit per case
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.
Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.
Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.
Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.
Condies Foods Fresh Fruit, Item Number 40781, UPC 50777222655
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.
Blommer Chocolate Company ERNIES (chocolate candy centers with candy shell) Net Wt. 25 lbs. Ingredients: Sugar, cocoa, hydrogenated palm kernel oil, whey, artificial color (FD&C Blue No. 1, Blue No 1 Lake, Blue #2 Lake, Yellow #5, Yellow No. 5 Lake, Yellow No. 6, Yellow No. 6 Lake, Red No 40, Red No 40 Lake, Sorbitol, Titanium dioxide, phosphoric acid, methyl and propyl parabens and caramel), nonfat milk powder, corn syrup, soy lecithin added as an emulsified, wax dextrin and vanillin. (an artificial flavor) UPC U173419 FPC-ERN 15025CN Blommer Chocolate Company, 1515 Pacific Street, Union City, CA 87
SAF PRO RELAX +YF, Deactivated Dry Yeast, Product Code 73050, Net Wt. 50 LBS. (22.7 KG), manufactured for Lesaffre Yeast Company, Milwaukee, WI.
Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
Major Poly-Vita Drops 50 mL UPC 00904-5099-50
Leader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL UPC 096295128611
Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97
Leader Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL UPC 096295128628
Rugby Ferrous Sulfate Elixir 473 mL UPC: 00536-0650-85
Major Ferrous Drop Iron Supplement 50 mL UPC 00904-6060-50
Rugby Tri-Vitamin Liquid 1 2/3 fl. oz. (50 mL) UPC 00536-8501-80
Rugby Calcionate Syrup 16 oz. UPC 00536-2770-85
Major Certa-Vite Liquid 236 mL UPC 00904-5023-09
Rugby Polyvitamin Liquid 1 2/3 fl. oz. (50 mL) UPC 00536-8450-80
Rugby Cerovite Liquid 236 mL UPC 00536-2790-59
Rugby Poly-Vitamin w/ Iron Liquid 50 mL UPC 00536-8530-80
Major Poly-Vita Drops w/ Iron 50 mL UPC 00904-5100-50
Rugby D3 Vitamin liquid 400 IU/1 mL dose 1 2/3 fl. oz. (50 mL) UPC 00536-8400-80
Major Tri-Vita Drops 50 mL UPC 00904-6274-50
Rugby FER Iron Liquid 50 mL UPC 00536-0710-80
Major D-Vita Drops 50 mL UPC 00904-6273-50

Reason for Recall
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
The expiration date provided on the label is incorrect.
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
The firm distributed product without ingredient statement or labeling. Product contains various allergens.
Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which did not meet acceptable product specifications for release, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Blood product collected from a donor who traveled to a malarial endemic area, was distributed.
potentially been contaminated with Listeria monocytogenes
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab.
Microbial Contamination of Non-Sterile Products.
Blood products, in which quality control for WBC count was not performed, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who lived in a malarial endemic area, was distributed.
Condies Foods is recalling Veggie Cups due to undeclared milk and egg.
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
During sanitation activities it was noticed that two light shields had pieces missing and potentially could have gotten into finished products.
Blood products, which were not prepared within the appropriate time frame after collection, were distributed.
. Milk is declared in the ingredients statement, but not in the Contains statement.
Product has potential to be contaminated with pieces of metal.
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Blood product, collected from a donor who took medication that may affect platelet function, was distributed.
Apheresis products, in which quality control for WBC count were not performed, were distributed.
Presence of yeast and potential contamination with B. cepacia.

Code Info
UDI: 30382904433766. All Lot numbers: Not Distributed in US Not Distributed in US
UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.
UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.
lots 312544,312807; no UPC; Use By Dec 29 - Jan 2.
UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
Catalog ID: 532.021 VET Serial #: 190673
Lot U173419; Best Before: 12/17/2018 - New Century Snacks