FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Check against the official notice below — it lists the full affected range.
Avid Medical, Inc. is recalling 720 Fistula On-Off Kits (Part Number MMTN020) distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee. The kits are being recalled because the BD ChloraPrep 3mL applicator component may experience a breach in package integrity. Under certain circumstances, Aspergillus penicillioides fungus may grow on the applicator, potentially causing the package to breach and contaminate other components within the kit. The affected kits have Lot Number 1351695 with an expiration date of October 31, 2021, and Package GTIN 20809160223489.
The source document does not specify what remedy is available to consumers who have this product.
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: 720 kits Lot/code info: Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.