CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference recalled
Cook Incorporated is recalling Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference, distributed nationwide in the US. The recall was initiated on 16 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1833-2022
- FDA event ID
- 90793
- Recalling firm
- Cook Incorporated, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Aug 2022
- FDA classified
- 28 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 16 Aug 2022 | Recall initiated by company | |
| 28 Sep 2022 | Classified by FDA | +43 days |
| 5 Oct 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Domestic distribution nationwide. Foreign distribution worldwide.
Questions about this recall
Is Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference recalled?
Yes. Cook Incorporated recalled Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference on 16 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1833-2022.
Why was it 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.
Which lots are affected?
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
Where was it sold?
Domestic distribution nationwide. Foreign distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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