Recall Z-0315-2018— Centurion Medical Products Corporation

Name: FDA recall Z-0315-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-05

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2017-07-05, terminated 2018-03-09. It names one FDA 510(k) clearance: K951254. Product: SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.. Reason: 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..

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Terminated: 2018-03-09
Firm location: Williamston, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K951254 — SAFETYGLIDE NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1995-10-07

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

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

Reason for recall

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.

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