FDA-Device2026-06-17Class IIPROCESSING DEFECT

Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection component

OTHERNationwide distributionMedical devices

What this means

Avanos Medical included lidocaine hydrochloride injection in CORFLO Safety PEG Kits that was subject to a supplier recall due to quality issues. The affected kits were distributed nationwide. No injuries have been reported.

  • Check if you have CORFLO Safety PEG Kit Model 30-6312, Lot Number 30365228
  • Do not use the kit if you have it
  • Contact Avanos Medical for instructions on return or replacement
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
31 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2026

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