FDA-Device2026-06-17Class IIPROCESSING DEFECT
Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine component
What this means
Avanos Medical included lidocaine hydrochloride injection with quality issues in CORFLO Safety PEG feeding tube kits. The lidocaine was subject to a supplier recall and should not have been distributed in these sterile kits. The affected kits were distributed nationwide.
- Check if you have CORFLO Safety PEG Kit model 50-6316 with lot numbers 30365233, 30367015, 30372821, or 30378386
- Do not use the kit if you have one of the affected lot numbers
- Contact your healthcare provider or Avanos Medical 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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
54 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: 50-6316 Product Description: Feeding Tube Kit Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2026Want us to check the next one for you?
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