Recall Z-0130-2020 ยท MRZ Accessories, Pump, Infusion
ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
| Date | Jul 29, 2019 |
| Status | Terminated |
| Reason | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| Root cause | Under Investigation by firm |
| Action | ICU Medical notified customers, via Stericycle, Inc., on about 07/29/2019 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Customers were instructed to check inventory and quarantine any sets that are affected by the recall, return them to ICU Medical, inform potential users within your organization of the recall, and complete and return the provided response form. Please notify customers if affected product was further distributed and request that they contact Stericycle at 1-855-311-5437 (M-F, 8am-5pm ET) to receive a reply form. Customers were also requested to consider the following si |
| Quantity | 45,900 units |
| Distribution | 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, Germa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171346 | Sapphire Sets Icu Medical, Aug 25, 2017 |