FDAFDA · Food and drugs·Recall number Z-0566-2022
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Published February 16, 2022 · Recall initiated: December 22, 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
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Avanos Medical, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada and Chile.
- Lot
- 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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