basixALPHA Inflation Device 30 atm/bar recall
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and…
Why was basixALPHA Inflation Device 30 atm/bar recalled?
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: IN3130 UDI: 00884450440179; 00884450510155; Lot Numbers: H1862928; H1896261; H1923761; H1929106; H1939255; H1966485; H1978295; H2068264; H2073193; H2073247; H2077173; Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262; H1909581; H1923762; H1929107; H1978299; H2007415; H2031599; H2068265; H2073248; H2077175; H2084368; Catalog Number: IN3302 UDI: 00884450511305 Lot Numbers: H1896263; H1966489; Catalog Number: IN3802 UDI: 00884450511510 Lot Numbers: H18962650; H1939259; H1966490; H1973390; H1978305; H1993118; H2001426; H2007417; H2012534; H2031601; H2073198; H2073249; H2077176;
- Product
- basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 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.
- Recall date
- August 4, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)