États-Unis Recalls

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed By: Kerry Inc, Beloit, WI 53511.

Undeclared allergen (egg)

Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF, Raw Peeled & Deveined Tail Off, Gross Weight: 5 lb., packaged in polyethylene bags, packed 6 bags per case, Product of India, Farm Raised, for food service only

Nitrofurans detected in product

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF

Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Lidl US Recalls Vitasia Asian Style Wok Spice Mix Due to Potential Salmonella Contamination

Frankie's Organic Issues Allergy Alert on Undeclared Milk in Frankie’s Organic Plant-Based Vegan Cheddar Puffs

Recall of Jalapeno Avocado Dressing Because of Possible Health Risk

Henkel Corp. Announces a Nationwide Recall of Schwarzkopf Professional Osis Grip 6.76 fl. Oz/200 ml Due to Packaging Imperfection

Blue Bird Body Company - Damaged Wiring May Disrupt Critical Safety Functions

An electrical short can cause a disruption to safety functions such as a loss of rear lighting or instrument panel warning lights, increasing the risk of a crash.

Blue Bird Body Company - Damaged Wiring May Disrupt Critical Safety Functions

An electrical short can cause a disruption to safety functions such as a loss of rear lighting or instrument panel warning lights, increasing the risk of a crash.

Daimler Trucks North America, LLC - Fuel Tank Cage Incompatible with Fuel System/FMVSS 301

During a crash, an incompatible fuel tank cage and fuel system may result in a fuel leak, increasing the risk of a fire.