Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery 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: This is a Class II recall involving a sterile barrier breach on medical devices used in sensitive surgical procedures (ophthalmic surgery). While the potential hazards are serious (infection and vision loss), no illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product with no reported injury, warranting a score of 3 (High).
Plain-English summary
Covidien LP is recalling 12,732 units of surgical sutures, including monofilament nylon sutures and coated braided silk sutures sold under the McKesson brand.
The breather pouch on these suture packages has a sterile barrier breach. This breach may allow contamination to occur, potentially resulting in infection or vision loss when the sutures are used in ophthalmic (eye) procedures, particularly where there is direct patient contact during surgery.
The affected sutures were distributed nationwide throughout the United States and to numerous countries internationally. Healthcare facilities, surgical centers, and providers across these regions that obtained these products should be aware of this recall.
The recalled product
- Product
- Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11
- Manufacturer
- Covidien, LP
- Affected units
- 12,732
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 (5)
- GTIN: 20612479214235
- 20612479214419
- 20612479214495
- 20612479213283
- 20612479214235
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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