Moderate riskFDA DeviceClass II

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

Avanos Medical included lidocaine hydrochloride injection with quality issues in CORFLO Safety PEG feeding tube kits. The lidocaine was subject to a supplier recall and should not have been distributed in these sterile kits. The affected kits were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have CORFLO Safety PEG Kit model 50-6316 with lot numbers 30365233, 30367015, 30372821, or 30378386
  2. Do not use the kit if you have one of the affected lot numbers
  3. Contact your healthcare provider or Avanos Medical 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 with ENFit Connector Model/Catalog Number: 50-6316 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
54 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2340-2026

In the FDA's words

Description
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 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 10350770007530, Lot Numbers 30365233, 30367015, 30372821, 30378386 Distribution: US Nationwide distribution. Affected quantity: 54 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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