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Silkam
B BRAUN SURGICAL SA · Model X0762024 · UDI-DI 04038653971978
GAP
Prescription
10
510(k) clearances
3,977
Adverse events (8 deaths)
28
Recalls
121
Facilities
Description
SILKAM BLACK 6/0 (0.7) 45CM DS9
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-25 | Covidien, LP | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which |
| 2023-12-21 | Covidien LP | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could r |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2020-06-10 | Ethicon, Inc. | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years |
| 2018-12-18 | Ethicon, Inc. | The sutures inside the packaging are not the same size or type as indicated on the label. |
| 2014-10-17 | Ethicon, Inc. | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.