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Class 2 Device Recall The Coaxial MicroIntroducer i |
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Date Initiated by Firm |
September 08, 2016 |
Date Posted |
November 18, 2016 |
Recall Status1 |
Terminated 3 on September 08, 2017 |
Recall Number |
Z-0623-2017 |
Recall Event ID |
75145 |
510(K)Number |
K071574
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Product Classification |
Introducer, catheter - Product Code DYB
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Product |
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.
The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration. |
Code Information |
GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646. |
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 Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
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FDA Determined Cause 2 |
Process design |
Action |
Greatbatch sent a "Urgent Medical Device Recall" letter dated September 7, 2016 to all affected customers .The letter described the product, "Reason for Field Correction Action", "Risk to Health" , "Replacement Devices", & "Instructions to Customers" . Advised customers to quarantine the product and contact end users and share the recall information with them. Requested consignees to complete & return the Field Recall Response Form.
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 |
23,075 |
Distribution |
US: NY, TX. |
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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