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U.S. Department of Health and Human Services

Class 2 Device Recall Advance 35LP LowProfile PTA Balloon Dilatation Catheter

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 Class 2 Device Recall Advance 35LP LowProfile PTA Balloon Dilatation Cathetersee related information
Date Initiated by FirmApril 16, 2018
Create DateApril 25, 2018
Recall Status1 Terminated 3 on June 27, 2019
Recall NumberZ-1521-2018
Recall Event ID 79861
510(K)NumberK091527 
Product Classification Catheter, percutaneous - Product Code DQY
ProductAdvance 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
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
812-339-2235
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.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 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 Commerce40 total products
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQY
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