Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture
Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source describes a structural defect (catheter tip fracture/separation) that can lead to complications such as occlusion of blood flow to end organs, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted here as significant medical risk from a structural failure).
Plain-English summary
Cook Inc. is recalling 2,280 units of Single Lumen Pressure Monitoring Sets and Trays. These medical devices consist of single-lumen catheters that are either uncoated or heparin-coated. The affected products were distributed worldwide, including in the United States, Puerto Rico, Australia, Germany, China, Chile, the Dominican Republic, Panama, Israel, Brazil, and Canada.
The recall is due to a manufacturing process issue that may lead to catheter tip fracture or separation. If a tip separates, it can cause loss of device function, require medical intervention to retrieve the separated segment, or result in complications if the tip blocks blood flow to end organs. These catheters are used for venous or arterial pressure monitoring, blood sampling, and the administration of drugs and fluids.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices. Users should verify if their specific catalog numbers and lot numbers match the list provided in the official recall notice.
The recalled product
- Product
- Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 2,280
Distribution
Part of a larger recall action
This product is one of 4 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.
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