Date Initiated by Firm | February 15, 2007 |
Date Posted | April 05, 2007 |
Recall Status1 |
Terminated 3 on July 19, 2007 |
Recall Number | Z-0719-2007 |
Recall Event ID |
37598 |
510(K)Number | K980987 |
Product Classification |
syringe - Product Code FMF
|
Product | BD 30ml Syringe Luer-Lok tip
Sterile
BD, Franklin Lakes, NJ
Made in USA |
Code Information |
Reorder number 309650 Lot numbers 6188613, 6188614 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact | Greg Morgan 201-847-4344 |
Manufacturer Reason for Recall | The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size. |
FDA Determined Cause 2 | Other |
Action | Distributors were sent recall notification letters on February 1, 2007
Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007. |
Quantity in Commerce | 332,400 units |
Distribution | Nationwide. |
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 = FMF
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