Dermalon Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.
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 sterile barrier breach in surgical sutures. Although no illnesses or injuries are reported in the source, the theoretical risk of infection or vision loss in ophthalmic procedures involving a compromised sterile barrier justifies a High severity classification.
Plain-English summary
Covidien, LP is recalling specific lots of Dermalon Monofilament Nylon Suture due to a sterile barrier breach in the breather pouch. The affected product includes five specific product codes with 6-0, 5-0, and 3-0 gauge sutures in blue color.
The sterile barrier breach in the breather pouch may compromise the sterile condition of the sutures. This defect may result in infection or vision loss when the sutures are used in ophthalmic procedures where there is direct patient contact.
Approximately 9,606 units were distributed nationwide in the United States and internationally to multiple countries. The recall applies to sutures with specific lot numbers including D2B0701Y, D2E3000Y, D1M2315FY, D1M2326FY, D2F1873FY, D2B2781FY, D2B1309FY, and D1J0777FY.
Healthcare facilities and practitioners should immediately discontinue use of affected lots. Users should consult the FDA recall notice for specific product codes and lot numbers to identify affected inventory in their facilities.
The recalled product
- Product
- Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
- Manufacturer
- Covidien, LP
- Hazard
- sterile-barrier-breach
- infection-risk
- 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 (3)
- D2E3000Y (2) D1M2315FY
- D1M2326FY
- D2F1873FY (3) D2B2781FY (4) D2B1309FY (5) D1J0777FY
Distribution
Distributed nationwide across the United States.
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