FDA Recall Terminated

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Recall: Z-0500-2020 · Initiated October 14, 2019

Recall

Recall Number
Z-0500-2020
Event Number
84113
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
NGT
Status
Terminated
Root Cause
Packaging process control
Initiated
October 14, 2019
Terminated
October 16, 2020
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Reason

Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

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.

Distribution

Distribution US Nationwide and Canada

Quantity

967,680