Device product
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.
Z-1312-2025
Product summary
- Firm
- Aesculap Inc
- Event
- Event 96223
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47,078 forceps
- Official record key
device-enforcement:Z-1312-2025
Official wording
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Code information: GTIN numbers: (1) REF BH951R - 04038653027026; (2) REF BH952R - 04038653139200; (3) REF BH957R - 04038653027033; (4) REF BH959R - 04038653027040; (5) REF BH961R - 04038653027057; (6) REF BH963R - 04038653027064; and (7) REF BH965R - 04038653027071.
Distribution pattern: Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Derived failure modes
-
Unknown
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.