Reported Oct 5, 2022 · Ongoing

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902…

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

22 of 22 products

Products covered by this recall
Model / numberProduct as published
G01602Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3
G00902TSCF-35-180-3
G00455TSCF-21-260-3
G02384THSCF-25-260-3
G00466TSCF-25-145-3
G04069THSCF-35-80-3
G01151THSCF-35-180-15
G00456TSCF-21-50-3
G00412THSCF-35-145-3
G00509TSCF-35-145-15
G00507TSCF-35-145-1.5
G00511TSCF-35-145-3
G00552TSCF-38-80-3
G02160TSCF-18-180-3
G00529TSCF-35-80-3
G01793TSCF-21-180-3
G00471TSCF-25-260-3
G02050C-SCF-18-50-3
G02659C-SCF-18-40-2
G02180C-SCF-25-50-3
Lot codes and dates

22 of 22 products

Products covered by this recall
#BarcodesProduct as published
100827002009028Lots/Expiration Dates: 14769750 03-06-2027 14795053 15-06-2027 14818416 29-06-2027 TSCF-35-180-3 G00902 UDI-DI: 00827002009028
200827002004559Lots/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
300827002023840Lots/Expiration Dates: 14795051 15-06-2027 14813712 27-06-2027 THSCF-25-260-3 G02384 UDI-DI: 00827002023840
400827002004665Lots/Expiration Dates: 14795058 15-06-2027 TSCF-25-145-3 G00466 UDI-DI: 00827002004665
500827002040694Lots/Expiration Dates: 14795071 15-06-2027 THSCF-35-80-3 G04069 UDI-DI: 00827002040694
600827002011519Lots/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
700827002004566Lots/Expiration Dates: 14798678 16-06-2027 TSCF-21-50-3 G00456 UDI-DI: 00827002004566
800827002004122Lots/Expiration Dates: 14802358 20-06-2027 THSCF-35-145-3 G00412 UDI-DI: 00827002004122
900827002005099Lots/Expiration Dates: 14803096 20-06-2027 TSCF-35-145-15 G00509 UDI-DI: 00827002005099
1000827002005075Lots/Expiration Dates: 14803101 20-06-2027 TSCF-35-145-1.5 G00507 UDI-DI: 00827002005075
1100827002005112Lots/Expiration Dates: 14803102 20-06-2027 TSCF-35-145-3 G00511 UDI-DI: 00827002005112
1200827002005525Lots/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
1300827002021600Lots/Expiration Dates: 14805745 21-06-2027 NS14805905 07-07-2027 TSCF-18-180-3 G02160 UDI-DI: 00827002021600
1400827002005297Lots/Expiration Dates: 14807601 22-06-2027 TSCF-35-80-3 G00529 UDI-DI: 00827002005297
1500827002017931Lots/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
1600827002004719Lots/Expiration Dates: 14813705 27-06-2027 TSCF-25-260-3 G00471 UDI-DI: 00827002004719
1700827002020504Lots/Expiration Dates: 14818414 29-06-2027 14818415 29-06-2027 C-SCF-18-50-3 G02050 UDI-DI: 00827002020504
1800827002026599Lots/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
1900827002021808Lots/Expiration Dates: NS14802359 20-06-2027 NS14818385 29-06-2027 C-SCF-25-50-3 G02180 UDI-DI: 00827002021808
2000827002004412Lots/Expiration Dates: NS14818386 29-06-2027 TSCF-18-80-3 G00441 UDI-DI: 00827002004412
Amount recalled
9,903 US; 5,185 OUS

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Cook Incorporated

15 in total.

All recall categories · Browse the whole archive

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.