Device product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Z-0137-2020
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 83549
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280,826 units
- Official record key
device-enforcement:Z-0137-2020
Official wording
Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Code information: Product Code: 140099290, Lot number 855575H, 865265H, 876065H, 885425H, 896175H, 918685H, 929095H, 925775H, 936455H, 945745H, 3849199, 3845287, 3864779.
Distribution pattern: Nationwide distribution to 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Derived failure modes
-
Unknown
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.