Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
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 medical device with potential for infection or vision loss in ophthalmic procedures. No reported illnesses or injuries; hazard is theoretical, applying the rubric rule that risk-of-harm products without reported injuries score at most 3.
Plain-English summary
Covidien, LP is recalling Surgipro Monofilament Polypropylene Sutures due to a sterile barrier breach of the breather pouch. The breach may result in infection or vision loss in patients undergoing ophthalmic (eye) procedures where the sutures come into direct contact with the eye.
Affected products include multiple lot numbers across product codes CP-535, CP-824, CP-825, and VP-543. A total of 8,604 units have been distributed nationwide in the United States and internationally.
No illnesses or injuries have been reported to date. Healthcare providers and patients who have received these sutures should contact Covidien, LP for further information or to arrange replacement product.
The recalled product
- Product
- Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
- Manufacturer
- Covidien, LP
- Hazard
- sterile-barrier-breach
- infection
- vision-loss
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 (4)
- GTIN: 20884521037868
- 20884521036519
- 20884523004387
- 20884521036540
Distribution
Distributed nationwide across the United States.
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