The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0631-2018·Announced 2018-02-21

Cook Central Venous Catheter Tray Recalled for Fit Issues

Cook Inc. is recalling 25 Central Venous Catheter Trays because they may not fit over the 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 involves a procedural delay rather than direct physical injury or death, fitting the criteria for a moderate severity rating.

Plain-English summary

Cook Inc. is recalling 25 units of the Central Venous Catheter Tray Triple Lumen Polyurethane (Catalog Identifier: C-UTLMYJ-501J). The recall is limited to Lot Number 5919800, which has an expiration date of May 30, 2018.

The recall was initiated because the central venous catheters may not fit over the 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 Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J 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
25

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): 5919800 (30-May-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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