Moderate riskFDA DeviceClass II

Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injections with quality defects in 234 sterile PEG kits. The injections were already the subject of a supplier recall. The kits affected are model 8170-24 in specific lot numbers distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have one of the affected lot numbers: 30371847, 30374834, 30378748, or 30380347.
  2. Contact Avanos Medical or your healthcare facility if you have one of these kits.
  3. Do not use the lidocaine injection included in affected kits.

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 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
234 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2349-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007837, Lot Numbers 30371847, 30374834, 30378748, 30380347 Distribution: US Nationwide distribution. Affected quantity: 234 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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