Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Recall
- Recall Number
- Z-0876-2015
- Event Number
- 69879
- Firm
- PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France
- FEI Number
- 3006942524
- Product Code
- MAV
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 6, 2014
- Posted
- December 29, 2014
- Terminated
- March 24, 2017
Description
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.
US Nationwide Distribution in the states of AZ and CO.
24821 units