Vereinigte Staaten Recalls

Kettle Cuisine Recalls Marketside Tomato Bisque Soup Kit – Sold Exclusively at Walmart Stores Because of Possible Health Risk

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.

Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree, 4oz/113g pouch, UPC 815367010780, PTO Item 10720. Distributed by: PT Organics Ltd, 333 South State St, Suite V-142, Lake Oswego, OR 97034. Product is pasteurized blend of banana and strawberry purees sold in single serve spouted flexible film pouch (4oz/113g) with red cap. It is intended for consumption by children aged +6 months. Each master case contains 10/4oz. pouches of PT Organics Banana Strawberry 1006034. The bar code on master case label is 00815367010797.

Possible foreign object (thin, soft plastic strands).

Clover Hill Dairy LLP, Soft Cuajada in Brine, sold in five (5) gallon and two (2) gallon buckets. Unknown information: labeling. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Clover Hill Dairy LLP, Sharp Cheese Snack Pack Sharp Stix White or Yellow. Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

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.

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, Pepper Jack)). Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Oma's Pride Voluntarily Recalls One Lot of Woof Complete Canine Chicken Recipe (6 Lb Bag) Because of Possible Salmonella Health Risk

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 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.

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

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: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791

Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.

STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 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.

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.

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.

Potential for breach in sterile barrier of device packaging.

Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Organics Banana & Strawberry, 4 oz food puree, UPC 815367010780.

Flexible food pouch may release thin plastic strips into food.