Z-0662-2019 Class II Terminated
FDA device recall Z-0662-2019 was initiated by ICU Medical, Inc. on Oct 5, 2018 and is designated Class II. Reason for recall: Potential for leakage due to defect in the thermoset check valve component. The recall status is terminated (terminated Mar 25, 2021). Affected quantity: 1,760 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Oct 5, 2018
- Termination Date
- Mar 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,760 units
Product Description
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Reason for Recall
Potential for leakage due to defect in the thermoset check valve component.
Distribution Pattern
United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0662-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026