Recall Z-1274-2015— Bard Access Systems

Name: FDA recall Z-1274-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-08

Class II · Terminated

Class II FDA medical device recall by Bard Access Systems, initiated 2014-08-08, terminated 2015-08-05. It names 2 FDA 510(k) clearances: K133856, K121073. 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.. 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..

Recalling firm: Bard Access Systems
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Terminated: 2015-08-05
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K133856 — POWERGLIDE MIDLINE CATHETERC.R. Bard, Inc.·cleared 2014-01-16
K121073 — POWERGLIDE MIDLINE CATHETERC.R. Bard, Inc.·cleared 2012-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.