FDA-Device2026-06-17Class IIPROCESSING DEFECT
Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
What this means
Avanos Medical included lidocaine hydrochloride injections with quality problems into 72 sterile CORFLO Safety PEG Kits. The lidocaine was subject to a supplier recall for manufacturing defects. The affected kits were distributed nationwide.
- Check if you have a CORFLO Safety PEG Kit (Model 50-5320) with lot numbers 30365231, 30371022, 30373824, 30378385, 30383807, or 30385321.
- Do not use the kit if you have one of the affected lot numbers.
- Contact Avanos Medical or your healthcare provider for instructions on replacement or proper handling.
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
72 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: 50-5320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2338-2026Want us to check the next one for you?
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