| Class 2 Device Recall ViaPeel PTFE Peelable Introducer | |
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
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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 |
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 |
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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
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