FDA Device recall Z-0876-2015
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monit…
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monit… by Perouse Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0876-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perouse Medical |
| Distribution | US |
Product
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
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
Identifiers
| code_info | All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0876-2015%22
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