Device product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Z-1274-2015
Product summary
- Event
- Event 70430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4375 units
- Official record key
device-enforcement:Z-1274-2015
Official wording
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.
Code information: Lot Numbers: REYE1308, REYE2224, REYD0054, REYE2225, REYE1434, REYE2226 Product codes: M120081, M120081D, M120101, M118081
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Sterility assurance
packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility