FDAClass IIMarch 25, 2015

BD Posiflush Saline Flush Syringe recall: Sterility Concern

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…

Why was BD Posiflush Saline Flush Syringe recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
Bard Access Systems
Quantity
16,410 units
Distribution
US Nationwide Distribution.
Recall date
March 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls