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U.S. Department of Health and Human Services

Class 2 Device Recall STafetMyGlide Needle, 22GA 11/2in

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  Class 2 Device Recall STafetMyGlide Needle, 22GA 11/2in see related information
Date Initiated by Firm July 05, 2017
Create Date January 04, 2018
Recall Status1 Terminated 3 on March 09, 2018
Recall Number Z-0315-2018
Recall Event ID 78810
510(K)Number K951254  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in
Centurion Convenience Kits.
Centurion component code BD17O1NS.
Code Information 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
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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