Recall Z-1786-2021— Avid Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Avid Medical, Inc., initiated 2021-04-09, terminated 2022-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03. Reason: 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..
- Recalling firm
- Avid Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-04-09
- Terminated
- 2022-07-18
- Firm location
- Toano, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.