FDAFDA · Food and drugs·Recall number Z-1785-2021
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Published June 16, 2021 · Recall initiated: April 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Avid Medical, Inc.
- Distributor
- Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
- Lot
- Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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