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Class 2 Device Recall Cordis MAXI LD PTA Dilatation Catheter |
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Date Initiated by Firm |
October 04, 2019 |
Create Date |
October 30, 2019 |
Recall Status1 |
Terminated 3 on December 14, 2020 |
Recall Number |
Z-0250-2020 |
Recall Event ID |
83977 |
510(K)Number |
K991811
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Product Classification |
Catheter, angioplasty, peripheral, transluminal - Product Code LIT
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Product |
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. |
Code Information |
Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 NW 60th Ave Miami Lakes FL 33014-2802
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For Additional Information Contact |
786-313-2000
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Manufacturer Reason for Recall |
Product was manufactured utilizing an expired inner body.
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FDA Determined Cause 2 |
Process control |
Action |
Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen.
Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units. |
Quantity in Commerce |
21 units |
Distribution |
US distribution to AL, AZ, FL, MN, and MO |
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 = LIT and Original Applicant = CORDIS CORP.
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