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Sklar®
SKLAR CORPORATION · Model 92-3360 · UDI-DI 10649111170010
1
510(k) clearances
274
Adverse events (5 deaths)
7
Recalls
63
Facilities
Description
LUIKART-BILL TRACTION HDL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-13 | COVIDIEN LLC | Sterilization method used was not consistent with the labeling and the approved sterilization method |
| 2019-03-13 | COVIDIEN LLC | Sterilization method used was not consistent with the labeling and the approved sterilization method |
| 2019-03-13 | COVIDIEN LLC | Sterilization method used was not consistent with the labeling and the approved sterilization method |
| 2018-12-28 | Fetzer Medical GmbH & Co. KG | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| 2018-12-28 | Fetzer Medical GmbH & Co. KG | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| 2018-12-28 | Fetzer Medical GmbH & Co. KG | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| 2018-12-28 | Fetzer Medical GmbH & Co. KG | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
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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.