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

Heavy Double Flexible Tipped Wire Guide, Guidewire Reference recalled

Cook Incorporated is recalling Heavy Double Flexible Tipped 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 codesTHDOC-35-60-0-3 G11949 UDI-DI: 00827002119499 Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 Lots/Expiration Dates: NS14818388 29-06-2027

Quantity recalled25 US

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-1835-2022
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

Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925

Where it was distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Nationwide

Questions about this recall

Is Heavy Double Flexible Tipped Wire Guide, Guidewire Reference recalled?

Yes. Cook Incorporated recalled Heavy Double Flexible Tipped Wire Guide, Guidewire Reference on 16 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1835-2022.

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?

THDOC-35-60-0-3 G11949 UDI-DI: 00827002119499 Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 Lots/Expiration Dates: NS14818388 29-06-2027

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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