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AESCULAP

AESCULAP, INC. · Model MB299R · UDI-DI 04046964683091

HDA Prescription
10
510(k) clearances
274
Adverse events (5 deaths)
7
Recalls
63
Facilities

Description

LUIKART-MCLANE Obstetrical Forceps, 15 1/2", (394 mm), non-sterile, reusable

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.