The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0633-2018·Announced 2018-02-21

Cook Inc. Recalls Central Venous Catheters Due to Fit Issues

Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a procedural delay rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall involving a defect that may cause inconvenience or minor operational issues.

Plain-English summary

Cook Inc. is recalling Central Venous Tray Triple Lumen Polyurethane Catheters, Catalog Identifier C-UTLMY-501J-CCT. The recall involves 50 units from Lot Number 5901462, which has an expiration date of 30-January-2018.

The recall was initiated because the central venous catheters may not fit over a guide wire. This defect potentially causes procedure delays. The product is designed for the treatment of critically ill patients for uses including drug infusions, central venous blood pressure monitoring, and blood sampling.

The affected units were distributed worldwide, including nationwide in the United States and in Belgium, India, Italy, Spain, and the United Kingdom. Healthcare facilities and consumers should stop using the affected lots and contact Cook Inc. for further instructions.

The recalled product

Product
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous…
Manufacturer
Cook Inc.
Category
Medical Device — Catheters
Hazard
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number (Expiration date): 5901462 (30-January-2018)

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Cook Inc. 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 5 products in this recall →

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