The Recall Desk
HighFDA (Devices)·Z-1846-2022·Announced 2022-10-05

Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect

Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with potential sterility compromise due to packaging seal defect. No illnesses or injuries have been reported. This meets the criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Cook Incorporated has recalled specific lots of Movable Core Wire Guide (Tapered Tefcor) guidewires due to a potential packaging defect. The company identified that the packaging seal—specifically the chevron seal—may be completely breached. A breach in this seal could compromise the sterility of the device, which is essential for any device intended for use inside the human body.

The affected lots are 14808819, NS14821223, and NS14851713, with expiration dates of 22 June 2027, 30 June 2027, and 21 July 2027 respectively. According to Cook, these specific lots have not been distributed beyond the company's distribution center.

The recalled product

Product
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Manufacturer
Cook Incorporated
Category
Medical Device — Interventional Guidewire
Hazard
  • sterility-compromise
  • packaging-defect

Distribution

Distributed nationwide across the United States.

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