Reported Jun 16, 2021 · Terminated
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Avid Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avid Medical, Inc. · 9000 Westmont Dr · Toano, VA · 23168-9351
Is this the product you have?
- FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit
- Avid Medical Part NumberVAMK024-03
- Lot codes and dates
- Part NumberVAMK024-03
- Package GTIN20809160342500
- Lot Number1445301 (Expiration
- Date04/30/2022)
- and 1445302 (Expiration Date04/30/2022)
- Amount recalled
- 160 kits
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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