Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Terumosee related information
Date Initiated by FirmNovember 23, 2015
Date PostedDecember 24, 2015
Recall Status1 Terminated 3 on August 01, 2017
Recall NumberZ-0551-2016
Recall Event ID 72828
510(K)NumberK133894 
Product Classification Syringe, antistick - Product Code MEG
ProductTerumo 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.
FEI Number 2243441
Recalling Firm/
Manufacturer		 Terumo Medical Corp
2101 Cottontail Lane
Somerset NJ 08873-1277
For Additional Information ContactMs. 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
ActionTerumo 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 Commerce80,500 units
DistributionCalifornia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MEG
-
-