| Class 2 Device Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter |  |
Date Initiated by Firm | May 01, 2013 |
Date Posted | August 07, 2013 |
Recall Status1 |
Terminated 3 on December 04, 2015 |
Recall Number | Z-1923-2013 |
Recall Event ID |
65322 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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Product | BD 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
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For Additional Information Contact | Ms. 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 |
Action | BD 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 Commerce | 37,906,400 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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