[pending] Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Pending LLM rewrite. Source: FDA_DEVICE Z-2281-2026.
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
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
The recalled product
- Product
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Manufacturer
- Covidien, LP
- 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 (8)
- 1. Product Number: 170053
- UDI-DI: 10884521126732
- UPN: 20884521126739
- Lot number: J5L2332Y
- 2. Product Number: 170071
- UDI-DI: 10884521126787
- UPN: 20884521126784
- Lot number: J5H2924Y
Distribution
Distributed nationwide across the United States.
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