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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Core Wire Guide (SafeTJ Curved)

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  Class 2 Device Recall Fixed Core Wire Guide (SafeTJ Curved) see related information
Date Initiated by Firm August 16, 2022
Date Posted September 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1833-2022
Recall Event ID 90793
510(K)Number K171764  
Product Classification Wire, guide, catheter - Product Code DQX
Product Fixed Core Wire Guide (Safe-T-J Curved), Guidewire
Reference Part Number/GPN:
TSCF-25-180-3 G01602
TSCF-35-180-3 G00902
TSCF-21-260-3 G00455
THSCF-25-260-3 G02384
TSCF-25-145-3 G00466
THSCF-35-80-3 G04069
THSCF-35-180-15 G01151
TSCF-21-50-3 G00456
THSCF-35-145-3 G00412
TSCF-35-145-15 G00509
TSCF-35-145-1.5 G00507
TSCF-35-145-3 G00511
TSCF-38-80-3 G00552
TSCF-18-180-3 G02160
TSCF-35-80-3 G00529
TSCF-21-180-3 G01793
TSCF-25-260-3 G00471
C-SCF-18-50-3 G02050
C-SCF-18-40-2 G02659
C-SCF-25-50-3 G02180
TSCF-18-80-3 G00441
C-SCF-15-30-2 G06973
Code Information TSCF-25-180-3 G01602 UDI-DI: 00827002016026 Lots/Expiration Dates: 14769750 03-06-2027 14795053 15-06-2027 14818416 29-06-2027 TSCF-35-180-3 G00902 UDI-DI: 00827002009028 Lots/Expiration Dates: 14774744 07-06-2027 14793143 14-06-2027 14793144 14-06-2027 14795155 15-06-2027 14795156 15-06-2027 14795157 15-06-2027 14797503 16-06-2027 14798672 16-06-2027 14805743 21-06-2027 14805744 21-06-2027 14816671 28-06-2027 14821171 30-06-2027 14822357 30-06-2027 14822382 30-06-2027 14822383 30-06-2027 TSCF-21-260-3 G00455 UDI-DI: 00827002004559 Lots/Expiration Dates: 14795051 15-06-2027 14813712 27-06-2027 THSCF-25-260-3 G02384 UDI-DI: 00827002023840 Lots/Expiration Dates: 14795058 15-06-2027 TSCF-25-145-3 G00466 UDI-DI: 00827002004665 Lots/Expiration Dates: 14795071 15-06-2027 THSCF-35-80-3 G04069 UDI-DI: 00827002040694 Lots/Expiration Dates: 14797500 16-06-2027 14803099 20-06-2027 14830991 07-07-2027 14832155 07-07-2027 14837668 12-07-2027 14843270 15-07-2027 THSCF-35-180-15 G01151 UDI-DI: 00827002011519 Lots/Expiration Dates: 14798678 16-06-2027 TSCF-21-50-3 G00456 UDI-DI: 00827002004566 Lots/Expiration Dates: 14802358 20-06-2027 THSCF-35-145-3 G00412 UDI-DI: 00827002004122 Lots/Expiration Dates: 14803096 20-06-2027 TSCF-35-145-15 G00509 UDI-DI: 00827002005099 Lots/Expiration Dates: 14803101 20-06-2027 TSCF-35-145-1.5 G00507 UDI-DI: 00827002005075 Lots/Expiration Dates: 14803102 20-06-2027 TSCF-35-145-3 G00511 UDI-DI: 00827002005112 Lots/Expiration Dates: 14803184 20-06-2027 14811921 24-06-2027 14811922 24-06-2027 14811923 24-06-2027 14811924 24-06-2027 14811925 24-06-2027 14815767 27-06-2027 14815768 27-06-2027 14815769 27-06-2027 14815770 27-06-2027 14826198 05-07-2027 14826199 05-07-2027 14826200 05-07-2027 14826201 05-07-2027 14826202 05-07-2027 14831157 07-07-2027 14831158 07-07-2027 14831159 07-07-2027 14831160 07-07-2027 14831162 07-07-2027 14835711 11-07-2027 14835712 11-07-2027 14835713 11-07-2027 14835715 11-07-2027 14835716 11-07-2027 14841791 14-07-2027 14841792 14-07-2027 14843520 15-07-2027 NS14841787 14-07-2027 TSCF-38-80-3 G00552 UDI-DI: 00827002005525 Lots/Expiration Dates: 14805745 21-06-2027 NS14805905 07-07-2027 TSCF-18-180-3 G02160 UDI-DI: 00827002021600 Lots/Expiration Dates: 14807601 22-06-2027 TSCF-35-80-3 G00529 UDI-DI: 00827002005297 Lots/Expiration Dates: 14808542 22-06-2027 14808543 22-06-2027 14808544 22-06-2027 14808547 22-06-2027 14808548 22-06-2027 14814967 27-06-2027 14814968 27-06-2027 14814969 27-06-2027 14814970 27-06-2027 14814971 27-06-2027 14814972 27-06-2027 14814973 27-06-2027 TSCF-21-180-3 G01793 UDI-DI: 00827002017931 Lots/Expiration Dates: 14813705 27-06-2027 TSCF-25-260-3 G00471 UDI-DI: 00827002004719 Lots/Expiration Dates: 14818414 29-06-2027 14818415 29-06-2027 C-SCF-18-50-3 G02050 UDI-DI: 00827002020504 Lots/Expiration Dates: NS14797765 16-06-2027 NS14802360 20-06-2027 NS14818383 29-06-2027 NS14827374 05-07-2027 C-SCF-18-40-2 G02659 UDI-DI: 00827002026599 Lots/Expiration Dates: NS14802359 20-06-2027 NS14818385 29-06-2027 C-SCF-25-50-3 G02180 UDI-DI: 00827002021808 Lots/Expiration Dates: NS14818386 29-06-2027 TSCF-18-80-3 G00441 UDI-DI: 00827002004412 Lots/Expiration Dates: NS14821725 30-06-2027 C-SCF-15-30-2 G06973 UDI-DI: 00827002069732 Lots/Expiration Dates: NS14821726 30-06-2027
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 9,903 US; 5,185 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
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