Z-0499-2020 Class II Terminated
FDA device recall Z-0499-2020 was initiated by Becton Dickinson & Company on October 14, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 16, 2020). Affected quantity: 1,632,000.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 14, 2019
- Termination Date
- October 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,632,000
Product Description
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
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.
Distribution Pattern
Distribution US Nationwide and Canada
Code Information
Lot Number: 9142881 UDI: 50382903065474