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 issues in 231 CORFLO Safety PEG Kits (model 30-4320). The lidocaine itself was recalled by its supplier due to manufacturing problems. The affected kits were distributed nationwide.
- Check if you have CORFLO Safety PEG Kit model 30-4320 with lot numbers 30365226 or 30382750.
- Do not use the lidocaine hydrochloride injection included in the kit.
- Contact Avanos Medical or your healthcare provider for instructions on obtaining a replacement kit or injection.
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
231 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2026Want us to check the next one for you?
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