Recall Weekly
Moderate riskFDA DeviceClass II

Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injections with quality issues in their MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) kits. The lidocaine was subject to a supplier recall for quality defects. About 6,000 kits were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have a MIC Safety PEG Kit (20 Fr, Model 8180-20) with one of the affected lot numbers: 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, or 80403342.
  2. Do not use the lidocaine injection included in the kit.
  3. Contact Avanos Medical or your healthcare provider for guidance on obtaining replacement kits or alternative lidocaine.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
6,005 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2351-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342 Distribution: US Nationwide distribution. Affected quantity: 6,005 kits
Hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

20 products in this recall

Avanos CORFLO, MIC PEG kits recalled for lidocaine quality issue

Avanos Medical is recalling 20 PEG feeding tube kits sold under the CORFLO and MIC Safety names. The kits were made with lidocaine hydrochloride injection that is itself subject to a supplier recall for quality issues. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

OtherMedical devicesSold nationwideMore from FDA Device