The Recall Desk
ModerateFDA (Devices)·Z-0630-2018·Announced 2018-02-21

Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.

What this means for you

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, but the source text explicitly states the hazard is a potential procedure delay rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity rating.

Plain-English summary

Cook Inc. is recalling 85 units of Central Venous Catheter Set Triple Lumen Polyurethane (Catalog Identifier: C-UTLM-501J). The recall involves specific lots with expiration dates of May 29, 2018, and June 2, 2018.

The recall was initiated because the central venous catheters may not fit over a guide wire. This defect can potentially cause delays during medical procedures. 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 products were distributed worldwide, including in the United States and in Belgium, India, Italy, Spain, and the United Kingdom. Healthcare facilities and consumers who have these specific products should stop using them and contact Cook Inc. for further instructions.

The recalled product

Product
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-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 blood p
Manufacturer
Cook Inc.
Category
Medical Device — Catheters
Hazard
Affected units
85

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 (2)

  • Lot Number (Expiration date): 5918090 (29-May-2018)
  • 5925813 (02-June-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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