Z-0315-2018Class II

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

Name: Z-0315-2018 SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits...
Creator: Centurion Medical Products Corporation
Published: 2017-07-05
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2017-07-05 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS on 2017-07-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0315-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Posted: 2018-01-04
Terminated: 2018-03-09
Recalling firm: Centurion Medical Products, LP
Product: SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Centurion Medical Products Corporation sent a notification mailed to the affected customers and distributors via Certified Mail Return Receipt on July 5, 2017
Distribution: US.
Product codes and lots: Material Description Batch Expiration 1 CHT122O CHESTTUBETRAY 2017032350 2018-10 2017032250 2018-06 2017030650 2018-08 2017010550 2018-06 2016121450 2018-06 2016120750 2018-06 2 CHT13OS CHEST TUBE INSERTION TRAY 2017030750 2018-07 3 CHT154O CHEST TUBE INSERTION TRAY 2016112850 2018-06 4 CVI3750 PIGTAIL ACCESSORY BUNDLE 2016121550 2018-09 2016111750 2018-08 5 CV14265 VASCULAR ACCESS INSERT KIT - PEDIATRICS 2017032850 2018-07 6 CV14360 DIALYSIS KIT 2017032250 2018-07 7 PT16O LUMBAR PUNCTURE TRAY 2016120950 2018-03 8 TC7910 TRACHEOTOMY TRAY 2016051950 2018-07 2016050250 2018-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0315-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0315-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-04

Product code FMI

K951254Class IISafetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1995-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)