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Avanos Medical, Inc.: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

Medical DevicesSource: FDA (device) · Date: 2026-06-17

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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: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
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 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342
Product quantity
6,005 kits
Voluntary mandated
Voluntary: Firm initiated
City
Alpharetta
State
GA
Country
United States
Event id
98907
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