Date Initiated by Firm |
August 16, 2022 |
Date Posted |
September 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1830-2022 |
Recall Event ID |
90793 |
510(K)Number |
K171997
|
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product |
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
|
Code Information |
PMG-18SP-60-COPE G05183
UDI-DI: 00827002051836
Lot/Expiration Date
14795012 15-06-2027
14801636 20-06-2027
14804264 21-06-2027
14804265 21-06-2027
14806984 22-06-2027
14806985 22-06-2027
14815841 27-06-2027
14815842 27-06-2027
14815852 27-06-2027
14815853 27-06-2027
14815854 27-06-2027
14819080 29-06-2027
14819081 29-06-2027
14831205 07-07-2027
14831206 07-07-2027
14841236 14-07-2027
PMG-18SP-100-COPE G05822
UDI-DI: 00827002058224
Lots/Expiration Dates
14797819 16-06-2027
PMG-18SP-125-COPE G10077
UDI-DI: 00827002100770
Lots/Expiration Dates
14809295 23-06-2027
14809296 23-06-2027
|
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 |
2,748 US; 302 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
|