FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: 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.
- Recall number
- Z-0275-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-10-08
- Posted
- 2009-11-17
- Terminated
- 2012-04-02
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K934370"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28