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Premicron
B BRAUN SURGICAL SA · Model C2027822 · UDI-DI 04046963652463
GAT
Prescription
10
510(k) clearances
20,010
Adverse events (39 deaths)
23
Recalls
248
Facilities
Description
PREMICRON WHITE 5/0(1)45CM 2XDR8 CV
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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 |
| 2019-08-15 | Musculoskeletal Transplant Foundation, Inc. | Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure. |
| 2019-02-21 | ArthroCare Corporation | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use |
| 2015-04-30 | Smith & Nephew, Inc. | Sterility of device maybe compromised |
| 2014-06-25 | Peters Surgical | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| 2014-06-25 | Peters Surgical | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| 2014-03-11 | Teleflex Medical | The products are being recalled because they did not meet minimum needle attachment strength requirements. |
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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.