Moderate riskFDA DeviceClass II

Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical's MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit 20 Fr includes lidocaine hydrochloride injection from a supplier that issued a recall due to quality problems. The affected kits were distributed nationwide; no injuries have been reported so far.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have lot numbers 30370714, 30373419, 30374048, or 30378746 (Model 7170-20).
  2. Contact Avanos Medical or your healthcare provider for guidance on the affected kits.
  3. Do not use the kit if you have one of the recalled lots.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
901 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2342-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 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. Lot Code: Model No 7170-20, UDI-DI 10350770007776, Lot Numbers 30370714, 30373419, 30374048, 30378746 Distribution: US Nationwide distribution. Affected quantity: 901 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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