Moderate riskFDA DeviceClass II

Avanos MIC Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injections with quality issues in sterile PEG (feeding tube) kits. The lidocaine was subject to a supplier recall for manufacturing defects. About 218 kits with specific lot numbers were affected nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have one of the affected lot numbers: 30371318, 30375469, or 30383056.
  2. Do not use the kit if you have an affected lot number.
  3. Contact Avanos Medical or your healthcare provider for instructions on returning or replacing the kit.

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 14 Fr PULL Model/Catalog Number: 8180-14
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 20 products — see all of them.

Details

Units affected
218 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2350-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007844, Lot Numbers 30371318, 30375469, 30383056 Distribution: US Nationwide distribution. Affected quantity: 218 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.

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