Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach
Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of 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 recall of a risk-of-harm medical device where no illnesses or injuries have been reported. The sterile barrier breach poses potential for serious harm (infection, vision loss in ophthalmic procedures), meeting the threshold for High severity, but without reported cases the score remains at 3 rather than 4.
Plain-English summary
Covidien, LP is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. This defect may compromise the sterility of the sutures, potentially allowing bacterial contamination.
The affected sutures pose a risk of infection or vision loss during ophthalmic procedures where there is direct patient contact. Approximately 40,152 units have been distributed in the United States and internationally across multiple countries. The recall affects multiple gauges and lengths of the product, with specific lot numbers identified by Covidien.
No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TIC
- 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 (20)
- GTIN: 20884521062303
- 20884521059570
- 20884521060101
- 20884521059006
- 20884521059396
- 20884521060682
- 20884521059013
- 10884521059290
- 20884521059297
- 20884521059280
- 10884521061194
- 20884521061191
- 20884521062327
- 20884521059204
- 20884521060637
- 20884521105192
- 20884521062921
- 10884521058620
- 20884521058627
- 20884521060170
Distribution
Distributed nationwide across the United States.
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