Home › B BRAUN SURGICAL SA › Premilene
Premilene
B BRAUN SURGICAL SA · Model C2090046 · UDI-DI 04046963629946
GAW
Prescription
10
510(k) clearances
19,686
Adverse events (226 deaths)
28
Recalls
110
Facilities
Description
PREMILENE 3/0 (2) 75CM HR30 (M)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 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 |
| 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 |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.