Device product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Z-1273-2015
Product summary
- Event
- Event 70430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 135,284 units
- Official record key
device-enforcement:Z-1273-2015
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: REXE0073, REXD0494, REYF0446, REXE0074, REXE0090, REYE1239, REXD1915, REXD2151, REXD2152, REYE1275, REYF0305, REXD2142, REYE1697, REXE0082, REYE1240, REYE0972, REXE0083, REXE0072, REXE0095, REYE1276, REXE0081, REYE1267, REYE1568, REXD1616, REXE0087, REYE1232, REYE1567, REXE0092, REXE0094, REYE1585, REXD1936, reye0216, REYE1707, REYE1270, REXE0075, REYF0303, reyd1639, REXE0084, REXE0088, REYE1566, REXD1918, REYE1266, REXE0091, REYE1694, REXD1930, REYE1231, REXD2153, REXD2154, REXE0076, REYE1693 Product codes: PA-0029, PA-0029YN, PA-0030, PA-0031, PA-0031YN, PA-0032, PA-0032YN, PA-0033, PA-0033YN, PA-0034, PA-0034YN, PA-0038, PA-0038YN, 2632010, 2632034, 2632210, 2632234, 2681910, 2682010, 2682034, 2682215, 2682234, 2131910, 2131975, 2132075, 2141910, 2142010, 2142075, 2142210, 2142275
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