PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
This recall has been terminated (originally issued March 11, 2020).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- March 11, 2020
- Terminated
- March 2, 2022
- Recall Number
- Z-1796-2020
- Quantity
- 1932
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)
Root Cause
Other
Action Taken
On 03/11/2020, Urgent Product Recall Notices were mailed via second day service. The recalling firm requests that customers immediately stop using, quarantine, and return the affected lots. Further, they requested that customers make personnel within their organization aware of this field action. If the product was further distributed to other facilities, institutions, or manufacturers, customers were asked to ensure this notice was immediately shared with them and note the quantity distributed on the customer response form. Customers with additional questions were encouraged to call 801-208-4381.