Avanos Medical, Inc.: Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Avanos Medical, Inc.
- Product
- Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
- Reason / hazard
- Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-04-30
- Code info
- Lot Code: Model No 30-6316, UDI-DI 10350770007561, Lot Numbers 30365229 and 30376100
- Product quantity
- 41 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Alpharetta
- State
- GA
- Country
- United States
- Event id
- 98907
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