Z-1796-2020 Class II Terminated
FDA device recall Z-1796-2020 was initiated by Merit Medical Systems, Inc. on March 11, 2020 and is designated Class II. Reason for recall: During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may… The recall status is terminated (terminated March 2, 2022). Affected quantity: 1932.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 11, 2020
- Termination Date
- March 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1932
Product Description
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Reason for Recall
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
Distribution Pattern
U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy
Code Information
SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)