FDA-Device2026-06-17Class IIPROCESSING DEFECT

Avanos Medical CORFLO Safety PEG Kit recalled for defective lidocaine injection

OTHERNationwide distributionMedical devices

What this means

Avanos Medical included lidocaine hydrochloride injection in sterile kits. The lidocaine was subject to a supplier recall due to quality issues. The affected kits were distributed nationwide.

  • Check your kit's lot number: 30365229 or 30376100, Model 30-6316.
  • Do not use the kit if you have one of the affected lots.
  • Contact Avanos Medical or your healthcare provider for instructions on replacement or safe disposal.
The agency's original wording
Hazard

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
41 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2026

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