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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable TearAway Introducer Sets

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  Class 2 Device Recall Disposable TearAway Introducer Sets see related information
Date Initiated by Firm June 06, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 on October 10, 2006
Recall Number Z-0065-06
Recall Event ID 32667
Product Classification Endoscope, Neurological - Product Code GWG
Product Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
Code Information Lot No. 040508, 041111, 042116, 042367, 043146, 050077, 041464
Recalling Firm/
Remington Medical Inc.
6830 Meadowridge Ct
Alpharetta GA 30005-2202
For Additional Information Contact Maria Granito
Manufacturer Reason
for Recall
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
FDA Determined
Cause 2
Action A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
Quantity in Commerce 3180 units
Distribution AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI
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.