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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm October 14, 2019
Create Date November 20, 2019
Recall Status1 Terminated 3 on October 16, 2020
Recall Number Z-0499-2020
Recall Event ID 84113
510(K)Number K161552  
Product Classification Saline, vascular access flush - Product Code NGT
Product BD Posiflush Pre-Filled Normal Saline Syringes
Catalog Number: 306547
Code Information Lot Number: 9142881 UDI: 50382903065474
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
888-731-7973
Manufacturer Reason
for Recall		 Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
FDA Determined
Cause 2		 Packaging process control
Action BD issued notifications to Customers via FedEx to Distributors, Pharmacies, and Consumers via Pharmacies on 10/14/19, advising of the problem, health risk and action to take: Immediately review your inventory for the specific Catalog and Lot number listed , discontinue use and destroy all product subject to the recall following your institutions process for destruction.2. Complete the Customer Recall Response Form. Questions or require further assistance, please contact 1-888-731-7973 between 8 AM and 5 PM ET Monday through Friday.
Quantity in Commerce 1,632,000
Distribution Distribution US Nationwide and Canada
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 and Company
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