FDA-Device2026-06-17Class IIPROCESSING DEFECT
Avanos Medical CORFLO Safety PEG Kit recalled for defective lidocaine injection
What this means
Avanos Medical included lidocaine hydrochloride injection from a recalled supplier into 43 CORFLO Safety PEG Kits. The lidocaine had quality issues that could affect the sterility or safety of the kit. The affected kits were distributed nationwide.
- Check if you have lot numbers 30365232, 30367019, or 30380107 of the CORFLO Safety PEG Kit (model 50-6312).
- Do not use affected kits.
- Contact Avanos Medical for return or replacement instructions.
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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
43 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2026Want us to check the next one for you?
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