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Recall Observatory FDA recall evidence

Device product

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

Z-2351-2026

April 30, 2026

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 98907
Status
Ongoing
Classification
Class II
Quantity
6,005 kits
Official record key
device-enforcement:Z-2351-2026

Official wording

Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Code information: Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.