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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter

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 Class 2 Device Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adaptersee related information
Date Initiated by FirmMay 01, 2013
Date PostedAugust 07, 2013
Recall Status1 Terminated 3 on December 04, 2015
Recall NumberZ-1923-2013
Recall Event ID 65322
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductBD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Code Information Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347  Catalog number 367290, 367300 (CE), 368491, and 303380.
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactMs. Yogindra Dellow
201-847-6800
Manufacturer Reason
for Recall
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
FDA Determined
Cause 2
Under Investigation by firm
ActionBD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.
Quantity in Commerce37,906,400 units
DistributionNationwide 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.
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