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BR Surgical, LLC
BR Surgical, LLC · Model BR70-58134 · UDI-DI 00840183525828
10
510(k) clearances
92
Adverse events
4
Recalls
132
Facilities
Description
EMMETT Uterine Probe,11 3/4"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2016-10-28 | Hologic, Inc | Breach in sterile barrier compromising product sterility |
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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.