—#177219

Product

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

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K161552
Affected lot / code info: Lot Number: 9142881 UDI: 50382903065474

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distribution US Nationwide and Canada

Timeline

Recall initiated: 2019-10-14
Terminated: 2020-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.