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U.S. Department of Health and Human Services

Class 2 Device Recall BD PosiFlush SF Saline Flush Syringe

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  Class 2 Device Recall BD PosiFlush SF Saline Flush Syringe see related information
Date Initiated by Firm July 22, 2014
Date Posted September 22, 2014
Recall Status1 Terminated 3 on April 21, 2015
Recall Number Z-2673-2014
Recall Event ID 69047
510(K)Number K121050  
Product Classification Saline, vascular access flush - Product Code NGT
Product BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553.

Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
Code Information REF #306553  Lot numbers 3024261 - exp 12-2015  3046276 - exp 01-2016 4128353 - exp 04-2017
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mrs. Zuleika Sanchez
201-847-6800
Manufacturer Reason
for Recall		 BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
FDA Determined
Cause 2		 Packaging
Action BD sent recall letters/recall response cards dated 7/22/2014 via e-mail or UPS 2nd day mail. Customers are asked to examine their inventory and quarantine any affected product subject to recall. Customers should complete the Recall Response Card and fax it back to BD at 1-201-847-6990. Any questions can be directed to 1-888-237-2762 option 3.
Quantity in Commerce 3,088,320 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = BECTON DICKINSON & CO.
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