Z-1914-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2023
- Initiation Date
- April 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 436 units
Product Description
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Reason for Recall
There is a potential that valve assemblies will not open. preventing fluid from draining.
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.
Code Information
Lot # I2559297, I2564678, I2553915, I2614173, I2568219; UDI-DI: 00884450394939