Recall Z-2166-2021— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2021-06-10, terminated 2024-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.. Reason: Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-10
- Terminated
- 2024-05-15
- Firm location
- South Jordan, UT, United States
Product description
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Reason for recall
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Data sourced from openFDA. This site is unofficial and independent of the FDA.