ClearanceBrief
Recall Z-0315-2018 ยท FMI Needle, Hypodermic, Single Lumen

Centurion Medical Products Corporation

SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.

DateJul 5, 2017
StatusTerminated
ReasonCenturion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.
Root causeMaterial/Component Contamination
ActionCenturion Medical Products Corporation sent a notification mailed to the affected customers and distributors via Certified Mail Return Receipt on July 5, 2017
DistributionUS.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K951254SAFETYGLIDE NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 7, 1995