Date Initiated by Firm | March 16, 2017 |
Date Posted | April 06, 2017 |
Recall Status1 |
Terminated 3 on May 01, 2018 |
Recall Number | Z-1746-2017 |
Recall Event ID |
76826 |
510(K)Number | K945952 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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Product | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company
Product Usage:
The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations. |
Code Information |
Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18 Catalog Number: 369714 - Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18 Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact | Mr. Matthew Kelleher 201-847-6910 |
Manufacturer Reason for Recall | BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | BD sent an "Urgent Product Correction Letters and Customer Product Correction Response Forms" dated March 16, 2017 via email or UPS to their customers and distributors. |
Quantity in Commerce | 13,064,500 tubes (non-expired) |
Distribution | Worldwide - US 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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510(K) Database | 510(K)s with Product Code = JKA
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