Fistula recall: Contamination
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Why was Fistula recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)
- Product
- FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
- Recalling firm
- Avid Medical, Inc.
- Quantity
- 160 kits
- Distribution
- Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
- Recall date
- June 16, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)