SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 026 02 15 000
Date submitted:	2/8/2015

Manufacturer:	Baxter Healthcare
Device Type:	Syringe Tip Cap
Description:	Syringe tip cap
Medical Device Identifier:	Syringe Tip Cap Model H93866100, H93869100 Lot: all
Reason of Field Safety Corrective Action:	Baxter Healthcare identified that the affected products (Self-Righting Luer Slip and Luer Lock Tip Caps in the DISCPAC packaging) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol.
Remedy Action:	Baxter is requesting that you take the following actions: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures.
Athorized Representative/Importer/Distributor:	Baxter AG
Report Source:	Swissmedic
Source Ref. Number:	Vk_20150127_04
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Vk_20150127_04 ( Baxter Healthcare ).pdf

View History