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U.S. Department of Health and Human Services

Class 2 Device Recall ViaPeel PTFE Peelable Introducer

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  Class 2 Device Recall ViaPeel PTFE Peelable Introducer see related information
Date Initiated by Firm November 11, 2016
Create Date July 29, 2017
Recall Status1 Terminated 3 on November 03, 2017
Recall Number Z-2781-2017
Recall Event ID 76701
510(K)Number K072248  
Product Classification Introducer, catheter - Product Code DYB
Product ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Code Information Lot Number: W3101005
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information Contact local Greatbatch Medical representative
763-951-8235
Manufacturer Reason
for Recall		 Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
FDA Determined
Cause 2		 Process control
Action Consignee was sent via email on 11/11/2016 a Greatbatch "Urgent Medical Device Recall" letter dated November 2016. The letter described the product involved in the recall, Reason for Field Corrective Action, Risk to Health, Replacement Devices & Instructions to Customer. Advised consignees to quarantine the product, contact end users & complete and return the Field Recall Response Form to Stericycle at Greatbatch7893@stericycle.com or fax at 888-473-8015. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Greatbatch.com
Quantity in Commerce 5,000 devices
Distribution NY
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 = ENPATH MEDICAL, INC.
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