Recall Weekly
Moderate riskFDA DeviceClass II

Avanos Medical CORFLO Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injection from a recalled supplier into 43 CORFLO Safety PEG Kits. The lidocaine had quality issues that could affect the sterility or safety of the kit. The affected kits were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have lot numbers 30365232, 30367019, or 30380107 of the CORFLO Safety PEG Kit (model 50-6312).
  2. Do not use affected kits.
  3. Contact Avanos Medical for return or replacement instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
43 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2339-2026

In the FDA's words

Description
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007523, Lot Numbers 30365232, 30367019, 30380107 Distribution: US Nationwide distribution. Affected quantity: 43 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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