Recall Z-0499-2020

Becton Dickinson & Company · initiated October 14, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547

Codes / lots: Lot Number: 9142881 UDI: 50382903065474

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: Packaging process control

Action taken

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.

Details

Recall number
Z-0499-2020
Initiated
October 14, 2019
Terminated
October 16, 2020
Product code
NGT – Saline, Vascular Access Flush
Quantity
1,632,000
Distribution
Distribution US Nationwide and Canada
Recalling firm
Becton Dickinson & Company, Franklin Lakes, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0500-2020 Class IIBD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with… 10/14/2019Terminated