Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R

FDA device recall Z-1308-2025 · posted 2025-03-11 · Open, Classified

Recall details

Recalling firm

Aesculap Inc

Reason for recall

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

Action taken

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 customers. The correction is to be extended to the end user/customer level; (2) Determine the current inventory of the affected items and comply with the following instructions: (a) Use the products identified for clamping of tissue and small vessels only; (b) Inspect the products for end-of-life indicators prior to use; (c) Visually inspect the products which should be clean and free of any signs of corrosion and cracks. Check the joint and jaw in the open position from both sides (if needed, use magnification; (d) Test the function of the device, including the jaw area, for deformation and loss of tension. An Acknowledgment Form was enclosed for completion and return via FAX or email within 2 weeks of receipt, even if the total inventory in the consignee location is 0.

Root cause

Use error

Status

Open, Classified

Product code

HGC

Quantity affected

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.

Date initiated

2025-01-31

Date posted

2025-03-11

Location

Center Valley, PA