Moderate riskFDA DeviceClass II

Avanos Medical CORFLO Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injection in sterile kits. The lidocaine was subject to a supplier recall due to quality issues. The affected kits were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your kit's lot number: 30365229 or 30376100, Model 30-6316.
  2. Do not use the kit if you have one of the affected lots.
  3. Contact Avanos Medical or your healthcare provider for instructions on replacement or safe disposal.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
41 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2336-2026

In the FDA's words

Description
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Lot Code: Model No 30-6316, UDI-DI 10350770007561, Lot Numbers 30365229 and 30376100 Distribution: US Nationwide distribution. Affected quantity: 41 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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