Moderate riskFDA DeviceClass II

Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injections with quality issues in 231 CORFLO Safety PEG Kits (model 30-4320). The lidocaine itself was recalled by its supplier due to manufacturing problems. 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 30-4320 with lot numbers 30365226 or 30382750.
  2. Do not use the lidocaine hydrochloride injection included in the kit.
  3. Contact Avanos Medical or your healthcare provider for instructions on obtaining a replacement kit or injection.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 20 products — see all of them.

Details

Units affected
231 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2333-2026

In the FDA's words

Description
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007585, Lot Numbers 30365226 and 30382750 Distribution: US Nationwide distribution. Affected quantity: 231 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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