Date Initiated by Firm |
July 19, 2021 |
Create Date |
August 09, 2021 |
Recall Status1 |
Terminated 3 on February 16, 2023 |
Recall Number |
Z-2235-2021 |
Recall Event ID |
88348 |
510(K)Number |
K133843
|
Product Classification |
Catheter, angioplasty, peripheral, transluminal - Product Code LIT
|
Product |
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X |
Code Information |
Lot/Batch number 82219442 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 NW 60th Ave Miami Lakes FL 33014-2802
|
For Additional Information Contact |
786-313-2000
|
Manufacturer Reason for Recall |
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices. |
Quantity in Commerce |
8 units |
Distribution |
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = LIT and Original Applicant = CORDIS CORPORATION
|