Recall Z-0800-2016— Cook Inc.
Class I · Terminated
Class I FDA medical device recall by Cook Inc., initiated 2016-01-06, terminated 2017-08-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-01-06
- Terminated
- 2017-08-23
- Firm location
- Bloomington, IN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.