Recall Z-1308-2025 ยท HGC Clamp, Uterine
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 Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr
| Date | Mar 11, 2025 (initiated Jan 31, 2025) |
| Status | Open, Classified |
| Reason | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. |
| Root cause | Use error |
| Action | The recalling firm issued letters dated 1/29/2025 on 1/31/2025 via certified mail return-receipt. The letter explained the reason for the correction, identified the product impacted, provided the risk to health, and the actions required for the customer/user. The actions included: (1) Review the Urgent Medical Device Correction Notification in its entirety and ensure all users within the consignee organization are informed about the correction. Post the notification where the affected products are stored. If the consignee is a distributor, they are to forward the notification to their cust |
| Quantity | 19,979 forceps |
| Distribution | Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.