FDA Device recall Z-0662-2019
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090 by Icu Medical, citing potential for leakage due to defect in the thermoset check valve component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0662-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-05 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | 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 |
Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Reason
Potential for leakage due to defect in the thermoset check valve component.
Identifiers
| code_info | Item number: 41423-03. Lot numbers 3593903, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3593903. Lot number 359…Item number: 41423-03. Lot numbers 3593903, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3593903. Lot number 3598129, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3598129. Expiration Date 12/01/2020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2019%22
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