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Recall Observatory FDA recall evidence

Device product

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

Z-1912-2023

April 22, 2023

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 92301
Status
Ongoing
Classification
Class II
Quantity
156 units
Official record key
device-enforcement:Z-1912-2023

Official wording

Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information: Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173

Distribution pattern: Worldwide - 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential that valve assemblies will not open. preventing fluid from draining.