The Recall Desk
HighFDA (Devices)·Z-1844-2022·Announced 2022-10-05

Vinyl Connecting Tubes Recalled Due to Packaging Seal Breach

Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which 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 medical device recall with potential sterility compromise but no reported illnesses or injuries. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High (3) severity.

Plain-English summary

Cook Incorporated is recalling Vinyl Connecting Tubes distributed domestically throughout the United States and internationally. The recall involves five part number variants with specific lot numbers and expiration dates.

Cook Medical identified that devices from affected lots may have a complete breach of the chevron seal of the packaging, which may compromise the sterility of the affected devices.

The recall affects 240 units distributed in the United States and 108 units distributed internationally. Affected devices include part numbers CTU14.0-30-ST, CTU14.0-40-ST, CTU14.0-30, CTU14.0-50-ST, and C-CTU14.0-30-ST, identified by specific lot numbers with expiration dates between June and July 2025.

The recalled product

Product
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
Manufacturer
Cook Incorporated
Category
Medical Device — Medical Tubing
Hazard
  • sterility-breach
  • packaging-defect

Distribution

Distributed nationwide across the United States.

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