Recalls / —

—#86080

Product

Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. 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: REQI0632 REQJ0353 REQK0281 REQK0377 RERA0355 RERB0142 RERC0031 RERD0071 RERD0117 RERE0156 RERE0547 RERG0317 RERH0719 RERI0584 RERK0426 RERL0187 RESA0699 RESB0560 RESC0584 RESD0592 RESE0373 RESF0560 RESG0181 RESH0718 RESI0438 RESJ0549 RESJ0550 RETB0903 and RETB0904

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 #86080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.