Recall Z-1566-2021 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
| Date | Mar 16, 2021 |
| Status | Open, Classified |
| Reason | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Root cause | Component design/selection |
| Action | On 03/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL " Letter via Stericycle, Inc. informing customers that it has identified the potential for certain lots of Spiros to exhibit small amounts of leaks due to a molding defect. Customer are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check their inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their organization of this notification and complete the attached response form. Return the completed response form to the fax number or |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX Icu Medical, Inc., Aug 28, 2008 |