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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 18, 2022 · Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.