Recall Z-1524-2013
Bard Peripheral Vascular Inc · initiated April 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1524-2013
- Initiated
- April 16, 2013
- Posted by FDA
- June 8, 2013
- Terminated
- January 30, 2014
- Product code
- FZP – Clip, Implantable
- Quantity
- 3,085
- Distribution
- Worldwide Distribution: USA Nationwide and Internationally to Europe.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ