Aesculap Inc: Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach

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: 19,979 forceps Lot/code info: GTIN numbers: (1) REF BJ500R - 04038653139378; (2) REF BJ501R - 04038653139385; (3) REF BJ511R - 04038653139392; (4) REF BJ520R - 04038653139408; (5) REF BJ521R - 04038653139415; (6) REF BJ522R - 04038653139422; (7) REF BJ524R - 04046963364250; (8) REF BJ527R - 04038653139446; (9) REF BJ530R - 04038653139453; (10) REF BJ531R - 04038653139460; (11) REF BJ532R - 04038653139477; (12) REF BJ534R - 04038653027798; (13) REF BJ550R - 04038653139484; (14) REF BJ551R - 04038653139491; (15) REF BJ552R - 04038653139507; (16) REF BJ553R - 04038653139514; (17) REF MD591 - 04046963365592; and (18) REF MD592 - 04046963365608.

UPC codes

04038653139378, 04038653139385, 04038653139392, 04038653139408, 04038653139415, 04038653139422, 04046963364250, 04038653139446, 04038653139453, 04038653139460, 04038653139477, 04038653027798, 04038653139484, 04038653139491, 04038653139507, 04038653139514, 04046963365592, 04046963365608

Source

Official record: FDA (Device enforcement) ↗

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