Z-0138-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- July 29, 2019
- Termination Date
- January 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,400 units
Product Description
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.
Reason for Recall
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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.
Code Information
Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163)