Safetyglide Needle

• • Terminated Z-2889-2020 FDA Class II ·initiated 28 Jul 2020

  Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.

• • Terminated Z-0315-2018 FDA Class II ·initiated 5 Jul 2017

  Centurion 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.

• • Terminated Z-3116-2017 FDA Class II ·initiated 13 Jun 2017

  Presence of loose polypropylene foreign matter above release specification.

• • Terminated Z-2748-2017 FDA Class II ·initiated 16 Sep 2016

  BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

510(k) Number

K951254 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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