[pending] Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr P
Pending LLM rewrite. Source: FDA_DEVICE Z-2351-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
The recalled product
- Product
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot Code: Model No 8180-20
- UDI-DI 10350770007851
- Lot Numbers 20133232
- 30371326
- 30378749
- 30378751
- 30379686
- 30383063
- 30383057
- 80403339
- 80403342
Distribution
Distributed nationwide across the United States.
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