Z-0275-2010

Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Disposable Biopsy...

Name: Z-0275-2010 Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Disposable Biopsy...
Creator: Bard Peripheral Vascular Inc
Published: 2009-10-08
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2009-10-08 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies... on 2009-10-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0275-2010
Status: Terminated
Initiated: 2009-10-08
Posted: 2009-11-17
Terminated: 2012-04-02
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. 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.
Product code: FCG Biopsy Needle
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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 97, 257 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 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
Product codes and lots: Lot Number: REQI0629 REQJ0343 REQJ0532 REQK0096 REQK0816 REQK1003 REQL0205 RERA0274 RERA0460 RERB0017 RERB0780 RERC0826 RERE0097 RERE0818 RERG0080 RERH0564 RERI0055 RERI0585 RERJ0009 RERK0116 RERK0428 RERK0627 RERL0541 RESA0700 RESB0562 RESC0423 RESD0593 RESE0615 RESF0033 RESF0705 RESG0180 RESH0546 RESI0285 RESI0441 RESI0736 RESJ0139 RESJ0639 RESJ0672 RETA0569 RETB0187 RETB0214 and RETB0794

Product code FCG

K934370Class IIBip Biopsy Needle ModificationBip USA, Inc. / cleared 1994-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)