Recall Z-0258-2007
Medrad Inc · initiated September 29, 2006
Product
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.
Codes / lots: Catalog number 3006314 and 3008772
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.
FDA-determined 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.
Details
- Recall number
- Z-0258-2007
- Initiated
- September 29, 2006
- Posted by FDA
- December 15, 2006
- Terminated
- June 20, 2007
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 80 units
- 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.
- Recalling firm
- Medrad Inc, Indianola, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0259-2007 | Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an…Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible… | 09/29/2006Terminated |