Date Initiated by Firm |
August 16, 2022 |
Date Posted |
September 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1827-2022 |
Recall Event ID |
90793 |
510(K)Number |
K171764
|
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product |
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
|
Code Information |
TSFB-35-80 (GPN G01315)
UDI-DI 00827002270411
Lots 14751376
Expiration Date 25-05-2027
TSFB-35-145 (GPN G00691)
UDI-DI 00827002006911
Lots Expiration Dates
14813687 27-06-2027
14831302 07-07-2027
14831303 07-07-2027
14831304 07-07-2027
14831305 07-07-2027
14831307 07-07-2027
14831308 07-07-2027
14831309 07-07-2027
14831310 07-07-2027
14831311 07-07-2027
14831313 07-07-2027
14842394 14-07-2027
14842395 14-07-2027
14842396 14-07-2027
14842397 14-07-2027
14842398 14-07-2027
14842399 14-07-2027
14842400 14-07-2027
14842401 14-07-2027
TSFB-35-200 (GPN G01095)
UDI-DI 00827002010956
Lot/Expiration Date: 14816668 28-06-2027
|
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 |
5571 US, 409 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
|