Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
This recall has been terminated (originally issued March 11, 2013).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- December 13, 2012
- Posted
- March 11, 2013
- Terminated
- May 20, 2013
- Recall Number
- Z-0939-2013
- Quantity
- 260
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Distribution
Distributed in the states of CA, IL, and MA.
Lot / Code Info
Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Root Cause
Labeling design
Action Taken
Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.