Recall Z-0273-2010
Bard Peripheral Vascular Inc · initiated October 8, 2009
Product
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors
Codes / lots: Lot Number: REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 Lot Number REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 and RETC0214
Reason for recall
The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was no injury to the patient or user. When us
FDA-determined cause: Process design
Action taken
The recall notification was initiated by the firm issuing an urgent medical device notification to it's consignees on October 08, 2009 via USPS requesting them to check all inventory locations for the affected products, remove and return affected products to Bard. The consignees were instructed to complete and return a recall effectiveness check form. Bard provided this 800 number 1-800-321-4254 for any questions consignees may have.
Details
- Recall number
- Z-0273-2010
- Initiated
- October 8, 2009
- Posted by FDA
- November 17, 2009
- Terminated
- April 2, 2012
- Product code
- FCG – Biopsy Needle
- Quantity
- 127,169 units
- Distribution
- Nationwide and internationally to Canada Mexico Algeria Andorra Austria Bahrain Belarus Belgium Croatia Cyprus Czech Republic Denmark Finland France French Guiana Germany Gibraltar Greece Hungary Ireland Israel Italy Ivory Coast Kenya Kuwait Latvia Lebanon Luxembourg Malta Martinique Mauritius Morocco Netherlands New Caledonia Nigeria Norway Oman Poland Portugal Republic of Kosovo Republic of…
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0274-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-0275-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-0276-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |