Covidien EndoStitch loading unit pouches may have sterility-breaking holes
Covidien EndoStitch Polysorb Single Use Loading Units are being recalled because holes in the pouch may compromise the sterile barrier. 2,448 units are affected.
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: FDA Class II recall where the sterile barrier may be breached on a surgical device, a risk of harm with no injuries reported in the source.
Plain-English summary
The Covidien EndoStitch Polysorb Single Use Loading Unit, product numbers 170053 and 170071, is being recalled. The action covers 2,448 units across the lot numbers listed in the recall notice, including J5L2332Y.
The stated reason is that 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 FDA classified the action as Class II.
Distribution was nationwide in the United States and internationally to Austria, Canada, Denmark, France and other markets. The loading units are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Manufacturer
- Covidien, LP
- Affected units
- 2,448
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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