Z-1786-2021 Class I Terminated
FDA device recall Z-1786-2021 was initiated by Avid Medical, Inc. on April 9, 2021 and is designated Class I. 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 As… The recall status is terminated (terminated July 18, 2022). Affected quantity: 160 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 9, 2021
- Termination Date
- July 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 kits
Product Description
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
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 Pattern
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Code Information
Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)