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Class 2 Device Recall Advance 35LP LowProfile PTA Balloon Dilatation Catheter |
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Date Initiated by Firm |
April 16, 2018 |
Create Date |
April 25, 2018 |
Recall Status1 |
Terminated 3 on June 27, 2019 |
Recall Number |
Z-1521-2018 |
Recall Event ID |
79861 |
510(K)Number |
K091527
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Product Classification |
Catheter, percutaneous - Product Code DQY
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Product |
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524
Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
Code Information |
Catalog number: PTA5-35-135-6-2 .0 lot 8429883; Catalog number: PTA5-35-135-4-4.0 lot 8426883 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Cook Medical Customer Relations Department 812-339-2235
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Manufacturer Reason for Recall |
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
On April 16, 2018 Cook Medical Inc. mailed an Urgent Medical Device recall notification to affected customers. Customers were instructed to: 1) Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products; 2) Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit.
NOTE: Unaffected products that are returned will not be credited; 3) Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com); 4) Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com Cook Incorporated |
Quantity in Commerce |
40 total products |
Distribution |
Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru |
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 = DQY and Original Applicant = COOK, INC.
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