Moderate riskFDA DeviceClass II

Avanos Medical MIC Safety PEG Kit 24 Fr recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injections with quality issues in certain MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) feeding tube kits. The lidocaine was subject to a supplier recall due to manufacturing or quality problems. About 132 kits with specific lot numbers were affected.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have the affected kit (Model 7170-24, Lot 30370715, 30371329, or 30375466).
  2. Do not use the lidocaine injection from the kit.
  3. Contact Avanos Medical or your healthcare provider for instructions on replacement or safe use.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 20 products — see all of them.

Details

Units affected
132 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2343-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI: 10350770007790, Lot Numbers 30370715, 30371329, 30375466 Distribution: US Nationwide distribution. Affected quantity: 132 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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