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Merit Medical Systems, Inc. Recall 92301

Description: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc. Recall 92301 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1915-2023
Event ID92301
Event DescriptionAspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Product TypeDevices
DistributionWorldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Quantity1054 units
Recall ReasonThere is a potential that valve assemblies will not open. preventing fluid from draining.
Device Classification20230621
Device Code InfoLot # I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231; UDI-DI: 00884450394946
Center Classification Date20230614
Recall Initiation Date20230422
Recalling FirmMerit Medical Systems, Inc.
Initial Notification Letter
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