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Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Ukrop's Homestyle Foods Recalls Spaghetti and Chicken Products Due to Possible Foreign Matter Contamination

Product Contamination

American Regent, Inc. Animal Health Issues Nationwide Recall of Two Lots of Adequan® Canine and Two Lots of Adequan® I.M. Due to Visible Glass Fiber Material in the Product

Golden Link Recalls Fantastic Four Cups and Captain America Popcorn Helmet Containers with LED Lights Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Mandatory Standard for Consumer Products with Button Cell Batteries

The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. In addition, the products do not bear the warning labels required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.

FSIS Issues Public Health Alert for Chicken Salad Product that May Be Contaminated with Listeria

Product Contamination

Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers packed into "Wonton Noodles Net Wt. 5 LBS" plastic bags and sold as 10 units (4-lb bags)/case. Neither product has ingredient labeling information.

No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.

Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pure Cane Sugar, Sassafras Bark, Burdock Roots, Wild Cherry Bark, Molasses, Fresh Lemon Juice, Star Anise, Coriander Seeds, Whole Clove, Wintergreen Extract (no alcohol).

Unapproved food additive: sassafras bark.

FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Organic Moringa Powder; 15kg/bag (bulk); Product code: GJ96

Moringa Powder ingredient positive for salmonella

NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744

Undeclared sodium tripolyphosphate (STTP)

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

FSIS Issues Public Health Alert for Steak Burrito Product Due to Misbranding and Undeclared Allergen

Misbranding, Unreported Allergens

FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).

Due to device not having FDA Clearance

Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748

Undeclared sodium tripolyphosphate (STTP)

Island Pacific IMITATION CRAB FLAKES NET WT: 1.0 LB (454g) UPC: 0000000175012 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748

Undeclared sodium tripolyphosphate (STTP)

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091

Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.

Bon Bons Wholesale Ltd recalls various chocolate products because of undeclared milk and soya

Milk and soya These products contain milk and soya making them a possible health risk for anyone with an allergy or intolerance to milk or milk constituents and/or an allergy to soya.

Maple Leaf Foods Inc. Recalls Not Ready-To-Eat (NRTE) Bacon Product Imported without the Benefit of Import Reinspection

Import Violation

BCI Foods, Inc. Recalls Chicken Noodle Soup Product Imported without the Benefit of Import Reinspection

Import Violation

ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.