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Recall Observatory FDA recall evidence

Device product

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

Z-1272-2015

August 08, 2014

Class II

Product summary

Firm
Bard Access Systems
Event
Event 70430
Status
Terminated
Classification
Class II
Quantity
16,410 units
Official record key
device-enforcement:Z-1272-2015

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: REYE1714, REYE1713, REXD1617, REXE0089, REXE0077, REYE1233, REXE0085, REXE0971, REYE1709, REYE1579, REXD2157, REYE1269, REXD1932, REXE0826, REXE0086, REXD2155, REXD2156, REXE0697. Product codes: 2651910, 2652010, 2652015, 2652034, 2652210, 2652234, 2671910, 2671934, 2672010, 2672034.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility