Date Initiated by Firm | April 16, 2013 |
Date Posted | June 08, 2013 |
Recall Status1 |
Terminated 3 on January 30, 2014 |
Recall Number | Z-1524-2013 |
Recall Event ID |
65046 |
510(K)Number | K993785 |
Product Classification |
Clip, implantable - Product Code FZP
|
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Bard Peripheral Vascular Inc 1625 W 3rd St Ste 109 Tempe AZ 85281-2438
|
For Additional Information Contact | 480-894-9515 |
Manufacturer 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 2 | 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 in Commerce | 3,085 |
Distribution | Worldwide Distribution: USA Nationwide and Internationally to Europe. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = FZP
|