Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.
This recall has been terminated (originally issued December 15, 2006).
- Company
- Medrad Inc
- Recall Initiated
- September 29, 2006
- Posted
- December 15, 2006
- Terminated
- June 20, 2007
- Recall Number
- Z-0258-2007
- Quantity
- 80 units
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
Distribution
Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan.
Lot / Code Info
Catalog number 3006314 and 3008772
Root Cause
Other
Action Taken
The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling.