Device product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Z-1275-2015
Product summary
- Event
- Event 70430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-1275-2015
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: 13FB8860 Product codes: CK000069
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