SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 064 10 16 001
Date submitted:	1/9/2017

Manufacturer:	Covidien LLC
Device Type:	Covidien Devon Light Gloves..
Description:	Light Handle
Medical Device Identifier:	Item Number: 31141784 Description: K-1960-S STANDARD MINI-KIT Item Number: 31140208 Description: 3611 FLEXBL LITE GLOVE 1EA/PKG Item Number: 31140216 Description: 3613 LITE GLV-FLEXIBLE 3EA/PKG Item Number: 31140257 Description: 3612 LITE GLV-FLEXIBLE 2EA/PKG Item Number: 571711 Description: NS-3600-B LITE GLOVE 1000/CASE
Reason of Field Safety Corrective Action:	Medtronic is issuing a labeling update for specific item codes of Covidien Devon™ Light Gloves.
Remedy Action:	-Please promptly forward this information to all customers you have distributed the affected devices listed on Attachment A. -The list of items on Attachment A includes the single sterile item codes and the bulk non sterile item code. ............. NCMDR update Action Medtronic requests that you quarantine and return any unused products of the item codes listed on Attachment A.(See attached FSN)
Athorized Representative/Importer/Distributor:	Covidien AG
Report Source:	NCMDR
Source Ref. Number:	102A5658DB1C3, 8F63566CB2266
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic.pdf

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