Z-0135-2020 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
- 4,600 units
Product Description
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
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: 240100401, Lot number (UDI Number): 897525H (20887787009259, 10887787009252), 905915H (20887787009259, 10887787009252), 926235H (20887787009259, 10887787009252)