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BR Surgical, LLC

BR Surgical, LLC · Model BR72-18421 · UDI-DI 00840183513344

HDA
10
510(k) clearances
275
Adverse events (5 deaths)
7
Recalls
63
Facilities

Description

GREEN ARMYTAGE Uterine Hemostatic Forceps, 8 1/4"

Recalls

DateFirmReason
2019-03-13COVIDIEN LLCSterilization method used was not consistent with the labeling and the approved sterilization method
2019-03-13COVIDIEN LLCSterilization method used was not consistent with the labeling and the approved sterilization method
2019-03-13COVIDIEN LLCSterilization method used was not consistent with the labeling and the approved sterilization method
2018-12-28Fetzer Medical GmbH & Co. KGThe firm had a report of doctors being unable to pull the obstetric forceps apart.
2018-12-28Fetzer Medical GmbH & Co. KGThe firm had a report of doctors being unable to pull the obstetric forceps apart.
2018-12-28Fetzer Medical GmbH & Co. KGThe firm had a report of doctors being unable to pull the obstetric forceps apart.
2018-12-28Fetzer Medical GmbH & Co. KGThe firm had a report of doctors being unable to pull the obstetric forceps apart.

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Data 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.