PreludeSYNC DISTAL Radial Compression Devices recall
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Why was PreludeSYNC DISTAL Radial Compression Devices recalled?
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.
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?
SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)
- Product
- PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1932
- 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
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)