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.
Reported: August 4, 2021 Initiated: June 10, 2021 #Z-2166-2021
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Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 7,211 devices
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 7,211 devices.
Why was this product recalled? ▼
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2166-2021.
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