CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report

Rosen Curved Wire Guide, Guidewire Reference recalled

Cook Incorporated is recalling Rosen Curved Wire Guide, 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

Lot, batch or date codesTHSCF-35-220-1.5-ROSEN G01623 UDI-DI: 00827002016231 Lots/Expiration Date: 14818344 29-06-2027 14820965 30-06-2027 14849857 20-07-2027 THSCF-35-80-1.5-ROSEN G01774 UDI-DI: 00827002017740 Lots/Expiration Date: 14820960 30-06-2027 14832877 08-07-2027 14847945 19-07-2027 THSCF-35-180-1.5-ROSEN G01264 UDI-DI: 00827002012646 Lots/Expiration Date: 14820961 30-06-2027 14843133 15-07-2027 14847946 19-07-2027 THSCF-35-145-1.5-ROSEN G01261 UDI-DI: 00827002012615 Lots/Expiration Date: 14820962 30-06-2027 14820963 30-06-2027 14820964 30-06-2027 14828587 06-07-2027 14835364 11-07-2027 14835365 11-07-2027 14849859 20-07-2027

Quantity recalled5041 US; 298 OUS

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-1842-2022
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

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261

Where it was distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Nationwide

Questions about this recall

Is Rosen Curved Wire Guide, Guidewire Reference recalled?

Yes. Cook Incorporated recalled Rosen Curved Wire Guide, Guidewire Reference on 16 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1842-2022.

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?

THSCF-35-220-1.5-ROSEN G01623 UDI-DI: 00827002016231 Lots/Expiration Date: 14818344 29-06-2027 14820965 30-06-2027 14849857 20-07-2027 THSCF-35-80-1.5-ROSEN G01774 UDI-DI: 00827002017740 Lots/Expiration Date: 14820960 30-06-2027 14832877 08-07-2027 14847945 19-07-2027 THSCF-35-180-1.5-ROSEN G01264 UDI-DI: 00827002012646 Lots/Expiration Date: 14820961 30-06-2027 14843133 15-07-2027 14847946 19-07-2027 THSCF-35-145-1.5-ROSEN G01261 UDI-DI: 00827002012615 Lots/Expiration Date: 14820962 30-06-2027 14820963 30-06-2027 14820964 30-06-2027 14828587 06-07-2027 14835364 11-07-2027 14835365 11-07-2027 14849859 20-07-2027

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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