Bard Peripheral Vascular Inc Recall: BARD Biopsy Systems (A Business Unit of Bard Peripher
Bard Peripheral Vascular Inc Recall: BARD Biopsy Systems (A Business Unit of Bard Peripher is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Bard Peripheral Vascular Inc; Product: BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tiss
| Recalling firm | Bard Peripheral Vascular Inc |
|---|---|
| Product | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). |
| Reason for recall | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY. |
| Recall initiated | 20130123 |
| Recall number | Z-1527-2013 |
| Category | device |
| State | AZ |
| Country | United States |
$29/mo
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