DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Check against the official notice below — it lists the full affected range.
Avid Medical, Inc. is recalling 560 DIALYSIS ACCESS Medical convenience kits (Part Number VMED004-03) that were distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee. The kits are being recalled because the BD ChloraPrep 3mL applicator component may have a breach in package integrity. Under certain circumstances, the applicator may grow Aspergillus penicillioides, a type of mold, which could result in a breach of the package integrity and potentially contaminate other components within the kit. The affected kits have four specific lot numbers with expiration dates ranging from October 1, 2021 to April 26, 2022.
The source document does not specify what consumers should do 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: 560 kits Lot/code info: Part Number:VMED004-03; Package GTIN: 20809160238247; Lot Number: 1409970 (Expiration Date: 04/26/2022), 1412734 (Expiration Date: 10/01/2021), 1413146 (Expiration Date: 10/01/2021), and 1413395 (Expiration Date: 04/25/2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.