Thermoset Room Temperature Closed Loop Injectate Delivery System — Class II medical device recall Z-0661-2019
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-0661-2019 |
|---|---|
| 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 | 27,250 units |
| Reason classes | packaging |
| Lot numbers | 04411, 0840619, 210101, 3591489, 3598125, 3608570, 3610798, 3618041, 3656677, 3665611 |
| Model numbers | 41412-01 |
| Expiration dates | 2021-01-01 |
Product
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
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-0661-2019. 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.