Iced Thermoset Closed-Loop Injectate Delivery System for cold… — Class II medical device recall Z-0663-2019
Terminated recall by ICU Medical, Inc., reported 2019-01-02, distributed in AL, CA, CO, DC, FL, GA, IN, KY…. Potential for leakage due to defect in the thermoset check valve component.
| Recall number | Z-0663-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2018-10-05 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2021-03-25 |
| Distributed | AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY |
| Quantity | 25,640 units |
| Reason classes | packaging |
| Lot numbers | 04414, 0840619, 3580033, 3580037, 3580038, 3585768, 3585769, 3585770, 3585771, 3585772, 3585773, 3585774, 3585775, 3598139, 3598143, 3610803, 3642242, 3656680 |
| Model numbers | 41424-03 |
Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Reason for recall
Potential for leakage due to defect in the thermoset check valve component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0663-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.