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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer

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 Class 2 Device Recall BD Vacutainersee related information
Date Initiated by FirmAugust 20, 2004
Date PostedOctober 28, 2004
Recall Status1 Terminated 3
Recall NumberZ-0052-05
Recall Event ID 30104
510(K)NumberK023075 K921806 K960250 
Product Classification glass and plastic - Product Code JKA
ProductBD Vactuainer SST glass and plastic tubes.
Code Information There is no linkage to any particular lot of BD product.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactKevin Nolan
201-847-5651
Manufacturer Reason
for Recall		"Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when
FDA Determined
Cause 2		Other
ActionThe firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.
Quantity in CommerceThere is no linkage to any particular lot of BD product
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
510(K)s with Product Code = JKA
510(K)s with Product Code = JKA
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