Recall Z-1524-2013 ยท FZP Clip, Implantable
Bard Peripheral Vascular Inc
BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
| Date | Jun 8, 2013 (initiated Apr 16, 2013) |
| Status | Terminated |
| Reason | Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use. |
| Root cause | Nonconforming Material/Component |
| Action | Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information. |
| Quantity | 3,085 |
| Distribution | Worldwide Distribution: USA Nationwide and Internationally to Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993785 | ULTRACLIP TISSUE MARKER Inrad, Feb 4, 2000 |