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Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-...

FDA Device Recall #Z-1834-2022 — Class II — August 16, 2022

Recall Summary

Recall Number Z-1834-2022
Classification Class II — Moderate risk
Date Initiated August 16, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Incorporated
Location Bloomington, IN
Product Type Devices
Quantity 5,669 US; 5,286 OUS

Product Description

Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408

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.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

Lot / Code Information

C-SF-18-30 G02261 UDI-DI: 00827002022614 Lot/Expiration Date: 14795056 15-06-2027 C-SF-25-40 G01937 UDI-DI: 00827002019379 Lot/Expiration Date: 14795057 15-06-2027 TSF-18-260 G00590 UDI-DI: 00827002005907 Lot/Expiration date: 14795061 15-06-2027 C-SF-25-50 G01938 UDI-DI: 00827002019386 Lot/Expiration Date: 14795064 15-06-2027 TSF-35-180 G00652 UDI-DI: 00827002006522 Lot/Expiration Date: 14795595 15-06-2027 14795596 15-06-2027 14798673 16-06-2027 14821167 30-06-2027 14822385 30-06-2027 14835601 11-07-2027 C-SF-18-40 G02255 UDI-DI: 00827002022553 Lot/Expiration Date: 14797774 16-06-2027 TSF-25-145 G00617 UDI-DI: 00827002006171 Lot/Expiration Date: 14798256 16-06-2027 14802353 20-06-2027 14821721 30-06-2027 TSF-32-145 G00638 UDI-DI: 00827002006386 Lot/Expiration Date: 14798677 16-06-2027 C-SF-15-50 G02274 UDI-DI: 00827002022744 Lot/Expiration Date: 14802345 20-06-2027 TSF-18-145 G00587 UDI-DI: 00827002005877 Lot/Expiration Date: 14802352 20-06-2027 TSF-18-50 G00593 UDI-DI: 00827002005938 Lot/Expiration Date: 14807597 22-06-2027 TSF-35-145 G00650 UDI-DI: 00827002006508 Lot/Expiration Date: 14809677 23-06-2027 14809679 23-06-2027 14809680 23-06-2027 14821849 30-06-2027 14821850 30-06-2027 14821851 30-06-2027 14821852 30-06-2027 14821853 30-06-2027 14821854 30-06-2027 14821855 30-06-2027 14827347 05-07-2027 14827348 05-07-2027 14827349 05-07-2027 14827350 05-07-2027 14827351 05-07-2027 14827352 05-07-2027 14827353 05-07-2027 14827354 05-07-2027 14827355 05-07-2027 14827356 05-07-2027 14827357 05-07-2027 14833106 08-07-2027 14833107 08-07-2027 14833108 08-07-2027 14833109 08-07-2027 14833110 08-07-2027 14833117 08-07-2027 14836092 11-07-2027 14836093 11-07-2027 14836094 11-07-2027 14836097 11-07-2027 14836098 11-07-2027 14842387 14-07-2027 14845716 18-07-2027 14845717 18-07-2027 14845718 18-07-2027 14845724 18-07-2027 14845725 18-07-2027 14851622 20-07-2027 14851625 20-07-2027 14851626 20-07-2027 NS14841737 14-07-2027 TSF-21-145 G00602 UDI-DI: 00827002006027 Lot/Expiration Date: 14813708 27-06-2027 THSF-35-180 G01237 UDI-DI: 00827002012370 Lot/Expiration Date: 14816669 28-06-2027 TSF-35-80 G00664 UDI-DI: 00827002006645 Lot/Expiration Date 14837671 12-07-2027 C-SF-25-30 G02163 UDI-DI: 00827002021631 Lot/Expiration Date: NS14773823 07-06-2027 C-SF-21-30 G02351 UDI-DI: 00827002023512 Lot/Expiration Date: NS14807611 22-06-2027 THSF-35-80 G02408 UDI-DI: 00827002024083 Lot/Expiration Date: NS14837667 12-07-2027 NS14837685 12-07-2027

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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