Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or h

FDA device recall Z-0800-2016 · posted 2016-02-24 · Terminated

Recall details

Recalling firm

Cook Inc.

Reason for recall

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 tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.

Action taken

On 1/6/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Root cause

Process control

Status

Terminated

Product code

DQY

Quantity affected

2280

Distribution

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

Date initiated

2016-01-06

Date posted

2016-02-24

Date terminated

2017-08-23

Location

Bloomington, IN