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
This recall has been terminated (originally issued December 29, 2014).
- Recall Initiated
- October 6, 2014
- Posted
- December 29, 2014
- Terminated
- March 24, 2017
- Recall Number
- Z-0876-2015
- Quantity
- 24821 units
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
US Nationwide Distribution in the states of AZ and CO.
Lot / Code Info
All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407
Root Cause
Device Design
Action Taken
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.