—#86079

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

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K934370
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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 Macedonia Reunion Romania Russia Saudi Arabia Senegal Serbia Seychelles Slovenia South Africa Spain Sweden Switzerland Syria Tunisia Turkey Ukraine United Arab Emirates United Kingdom Australia New Zealand Canada Japan Bangladesh China Hong Kong India Indonesia Korea Malaysia Pakistan Singapore Sri Lanka Taiwan Thailand Vietnam Argentina Bahamas Barbados Brazil Chile Colombia Dominican Republic Mexico Peru and Suriname

Timeline

Recall initiated: 2009-10-08
Posted by FDA: 2009-11-17
Terminated: 2012-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.