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.

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

On 06/08/2021, the firm sent an "URGENT PRODUCT RECALL NOTICE" initially via an email communication and then followed up with a hardcopy letter via FedEx overnight on 06/10/2021. The communication and letter informed customers that due to a design defect the handle of the inflation device may separate from the syringe during use, which may result in a delay in procedure. Customers are instructed to: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within their organization are made aware of this recall. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Fill out, scan, and email the completed CRF to Customer Service at [email protected] within 10 business days. All affected product shipped must be accounted for on the CRF. 5. Immediately return all affected lots in their possession to the Recalling Firm, per the instructions in the attached CRF. For any question contact the Recalling Firm's Representative or Customer Service at 801-208-4381 Monday thru Friday 6:00 am to 6 pm MDT.