—#117792

Product

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.

FDA product code: FZP — Clip, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K993785
Affected lot / code info: Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Ste 109, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Worldwide Distribution: USA Nationwide and Internationally to Europe.

Timeline

Recall initiated: 2013-04-16
Posted by FDA: 2013-06-08
Terminated: 2014-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117792. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.