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U.S. Department of Health and Human Services

Class 2 Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

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  Class 2 Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath see related information
Date Initiated by Firm June 07, 2017
Create Date December 08, 2017
Recall Status1 Terminated 3 on April 25, 2019
Recall Number Z-0230-2018
Recall Event ID 77661
510(K)Number K142183  
Product Classification Introducer, catheter - Product Code DYB
Product Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Code Information Lot s 161019, 161108, 161215, 170112, 170213, 170314
Recalling Firm/
Manufacturer
Terumo Medical Corp
2101 Cottontail Ln
Somerset NJ 08873-1277
For Additional Information Contact
908-302-4916
Manufacturer Reason
for Recall
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
FDA Determined
Cause 2
Nonconforming Material/Component
Action URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.
Distribution Nationwide and Canada
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 = DYB and Original Applicant = Terumo Medical Corporation
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