The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0802-2016·Announced 2016-03-02

Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets

Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated…"

Plain-English summary

Cook Inc. is recalling 12,691 units of Radial Artery Pressure Monitoring Catheter Sets and Trays. These medical devices are used for venous or arterial pressure monitoring, blood sampling, and the administration of drugs and fluids. The affected products are single-lumen catheters that are either uncoated or heparin-coated.

The recall was initiated because a manufacturing process may lead to catheter tip fracture or separation. If a tip separates, it may occlude blood flow to end organs, potentially requiring medical intervention to retrieve the separated segment or resulting in other complications.

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. Healthcare facilities and consumers should stop using these specific catalog numbers and lot numbers immediately and contact Cook Inc. for instructions on returning the devices.

The recalled product

Product
Radial Artery Pressure Monitoring Catheter 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
Hazard
Affected units
12,691

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 4 products in this recall →

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