Reported Mar 25, 2015 · Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in,…
Bard Access Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Access Systems · 605 N 5600 W · Salt Lake City, UT · 84116-3738
Is this the product you have?
- BD Posiflush Saline Flush Syringe 10 ml
- inlcuded in the following device kitsPowerLoc 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
- Lot codes and dates
- Lot Numbers
REYE1714REYE1713REXD1617REXE0089REXE0077REYE1233REXE0085REXE0971REYE1709REYE1579REXD2157REYE1269REXD1932REXE0826REXE0086REXD2155REXD2156REXE0697
- Product codes
2651910265201026520152652034265221026522342671910267193426720102672034
- Lot Numbers
- Amount recalled
- 16,410 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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