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Terminated

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

FDA Recall Z-0500-2020 · Posted None

Recall StatusTerminated
Product CodeNGT
Date Initiated2019-10-14
Date Terminated2020-10-16
Product Quantity967,680

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Distribution US Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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