Moderate riskFDA DeviceClass II

Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection

Avanos Medical included lidocaine hydrochloride injection with quality issues into CORFLO Safety PEG Kit sterile sets. The lidocaine was subject to a supplier recall for manufacturing defects. Sixty-one kits with six lot numbers were affected.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your kit lot number against: 30365227, 30368642, 30374529, 30376099, 30380696, or 30387248.
  2. If you have an affected lot, stop use and contact your supplier or Avanos Medical for replacement or guidance.
  3. Do not use the lidocaine injection from affected kits.

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: 30-5320
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
61 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2334-2026

In the FDA's words

Description
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007554, Lot Numbers 30365227, 30368642, 30374529, 30376099, 30380696, and 30387248 Distribution: US Nationwide distribution. Affected quantity: 61 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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