Moderate riskFDA DeviceClass II

Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injection from a supplier recall into 49 sterile CORFLO Safety PEG kits. The lidocaine was recalled by its supplier due to quality issues. Affected lot numbers are 30365230, 30367013, and 30373825.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have CORFLO Safety PEG Kit model 50-4320 with one of the affected lot numbers
  2. Contact Avanos Medical or your supplier for instructions on return or replacement
  3. Do not use kits with the affected lot numbers

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: 50-4320
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
49 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2337-2026

In the FDA's words

Description
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007578, Lot Numbers 30365230, 30367013, 30373825 Distribution: US Nationwide distribution. Affected quantity: 49 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.

Related topics