—#160571

Product

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K951254
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Material/Component Contamination

Action the firm took

Centurion Medical Products Corporation sent a notification mailed to the affected customers and distributors via Certified Mail Return Receipt on July 5, 2017

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: US.

Timeline

Recall initiated: 2017-07-05
Terminated: 2018-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.