—#86082

Product

Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. 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: REQJ0345 REQJ0534 REQK0287 REQK0817 REQK0993 RERA0224 RERA0592 RERA0755 RERB0582 RERC0904 RERD0210 RERD0711 RERF0404 RERG0082 RERH0917 RERJ0373 RERJ0643 RERJ0809 RERK0686 RERL0053 RESA0701 RESB0563 RESC0344 RESD0594 RESF0030 RESF0561 RESG0255 RESH0054 RESH0719 RESH0934 RESI0737 RESL0557 RETA0352 and RETB0215

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 #86082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.