FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Check against the official notice below — it lists the full affected range.
Avid Medical, Inc. is recalling 160 FISTULA (ON/OFF) ALL IN ONE BAG medical convenience kits (Part Number VAMK024-03) distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee. The kits are being recalled because a component—the BD ChloraPrep 3mL applicator—may experience a breach in package integrity. Under certain circumstances, the applicator may grow Aspergillus penicillioides fungus, which can compromise the package's seal and potentially contaminate other components within the kit.
The affected kits have Package GTIN 20809160342500 and include Lot Numbers 1445301 and 1445302, both with an expiration date of April 30, 2022. The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits. Distribution: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN Quantity: 160 kits Lot/code info: Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.