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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo

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  Class 2 Device Recall Terumo see related information
Date Initiated by Firm November 23, 2015
Date Posted December 24, 2015
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-0551-2016
Recall Event ID 72828
510(K)Number K133894  
Product Classification Syringe, antistick - Product Code MEG
Product Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Code Information Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
Recalling Firm/
Manufacturer		 Terumo Medical Corp
2101 Cottontail Lane
Somerset NJ 08873-1277
For Additional Information Contact Ms. Jennifer Suh
610-823-0273
Manufacturer Reason
for Recall		 Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
FDA Determined
Cause 2		 Process control
Action Terumo N.V. Europe notified their US Importer (Termumo Medical Corporation, Somerset, NJ) of the voluntary recall on 11/23/2015 via phone and email. Terumo Medical Corporation in turn notified their sole consignee on 11/24/2015 by email that included the manufacturers Recall Notification. The notification informed the customer of the reason for the recall; how to identify affected product; to immediately identify and quarantine any available stock; and complete and return the attached Reply Form.
Quantity in Commerce 80,500 units
Distribution California
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 = MEG and Original Applicant = TERUMO EUROPE N.V.
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