Date Initiated by Firm |
August 16, 2022 |
Date Posted |
September 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1831-2022 |
Recall Event ID |
90793 |
510(K)Number |
K171912 K181351
|
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product |
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
|
Code Information |
TDOC-35-145-0-3 G00362
UDI-DI: 00827002003620
Lots/Expiration Date:
14793053 14-06-2027
14797769 16-06-2027
14802346 20-06-2027
14802348 20-06-2027
14812034 24-06-2027
C-TDOC-18-50-0-2 G05146
UDI-DI: 00827002051461
Lots/Expiration Date:
14795065 15-06-2027
TDOC-35-50-0-3 G00364
UDI-DI: 00827002003644
Lots/Expiration Date:
14802347 20-06-2027
C-DOC-21-40-0-2 G02431
UDI-DI: 00827002024311
Lots/Expiration Date:
NS14795068 15-06-2027
C-TDOC-21-50-0-2 G05195
UDI-DI:00827002051959
Lots/Expiration Date:
NS14802356 20-06-2027
C-TDOC-25-50-0-2 G05145
UDI-DI: 00827002051454
Lots/Expiration Date:
NS14818384 29-06-2027
NS14818387 29-06-2027
|
Recalling Firm/ Manufacturer |
Cook Incorporated 750 N Daniels Way Bloomington IN 47404-9120
|
For Additional Information Contact |
Cook Medical Customer Relations Department 800-457-4500
|
Manufacturer Reason for Recall |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit.
If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235 |
Quantity in Commerce |
150 US, 97 OUS |
Distribution |
Domestic distribution nationwide. Foreign distribution worldwide. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = DQX and Original Applicant = Cook Incorporated
|