| | Class 2 Device Recall BD |  |
| Date Initiated by Firm | January 27, 2017 |
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| Create Date | November 09, 2017 |
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| Recall Status1 |
Terminated 3 on February 06, 2019 |
| Recall Number | Z-0084-2018 |
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| Recall Event ID |
78329 |
| Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
|
| Product | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960 |
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| Code Information |
Lot no. 6090812 |
| FEI Number |
2243072
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Recalling Firm/
Manufacturer |
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes
NJ
07417-1815
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| For Additional Information Contact |
888-345-8309 |
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Manufacturer Reason
for Recall | After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | BD notified their customers on 1/27/2017 via email and/or UPS 2nd Day Mail. Stericycle is handling returns. |
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| Quantity in Commerce | 90,000 tubes |
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| Distribution | Nationwide, Canada |
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| 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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