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Class 2 Device Recall ViaPeel PTFE Peelable Introducer |
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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
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Product Classification |
Introducer, catheter - Product Code DYB
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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
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For Additional Information Contact |
local Greatbatch Medical representative 763-951-8235
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Manufacturer Reason for Recall |
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = ENPATH MEDICAL, INC.
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