Z-0876-2015 Class II Terminated
FDA device recall Z-0876-2015 was initiated by PEROUSE MEDICAL on October 6, 2014 and is designated Class II. 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 The recall status is terminated (terminated March 24, 2017). Affected quantity: 24821 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2015
- Initiation Date
- October 6, 2014
- Termination Date
- March 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24821 units
Product 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
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 Pattern
US Nationwide Distribution in the states of AZ and CO.
Code Information
All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407