Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.

Part of a larger recall action

This product is one of 24 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
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Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · sterility breach