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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Glidesheath

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 Class 2 Recall
Terumo Glidesheath
see related information
Date Posted June 27, 2013
Recall Status1 Terminated on October 30, 2013
Recall Number Z-1612-2013
Recall Event ID 65397
Premarket Notification
510(K) Number
K102008 
Product Classification Introducer, Catheter - Product Code DYB
Product Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Code Information Lot MP08
Recalling Firm/
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton, Maryland 21921-5322
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Yusuke Shimpo
800-283-7866 Ext. 4967
Manufacturer Reason
for Recall
Medical devices were incorrectly labeled with extended expiration dates.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement.
Quantity in Commerce 550 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = TERUMO MEDICAL CORP.
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