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Moderate riskFDA DeviceClass II

Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine hydrochloride

Avanos Medical included lidocaine hydrochloride injection from a supplier recall into sterile PEG (feeding tube) kits due to quality issues with the lidocaine. The affected kits are the MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr, with specific lot numbers ranging from 30371313 to 80403340.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have one of the affected lot numbers (30371313, 30371314, 30373295, 30373296, 30374832, 30378735, or 80403340).
  2. Contact Avanos Medical or your healthcare provider if you have received one of these kits.
  3. Do not use the lidocaine from the affected kits until you confirm the lot number with your supplier or Avanos Medical.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 20 products — see all of them.

Details

Units affected
3,184 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2345-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007783, Lot Numbers 30371313, 30371314, 30373295, 30373296, 30374832, 30378735, 80403340 Distribution: US Nationwide distribution. Affected quantity: 3,184 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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