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U.S. Department of Health and Human Services

Class 2 Device Recall Needle, Biopsy

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  Class 2 Device Recall Needle, Biopsy see related information
Date Initiated by Firm October 08, 2009
Date Posted November 17, 2009
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-0276-2010
Recall Event ID 53615
510(K)Number K934370  
Product Classification kit, needle, biopsy - Product Code FCG
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.
Code Information 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             
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact
480-894-9515
Manufacturer 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
FDA Determined
Cause 2		 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 77, 848 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCG and Original Applicant = BIP USA, INC.
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