Aesculap Inc: Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF

Hazard

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Details from the source

Reason for recall: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Distribution: Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar. Quantity: 1,147 forceps Lot/code info: GTIN numbers: (1) REF FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) REF FB462R - 04038653156115; (5) REF FB469R - 04038653156184; (6) REF FB567R - 04038653156948; (7) REF FB568R - 04038653156955; (8) REF FB569R - 04038653156962; (9) REF FB729R - 04038653157617; (10) REF FB730R - 04038653157624; (11) REF FB736R - 04038653157686; (12) REF FB737R - 04038653157693; and (13) REF FB738R - 04038653157709.

UPC codes

04038653156078, 04038653156085, 04038653156108, 04038653156115, 04038653156184, 04038653156948, 04038653156955, 04038653156962, 04038653157617, 04038653157624, 04038653157686, 04038653157693, 04038653157709

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.