Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Reported: January 2, 2019 Initiated: October 5, 2018 #Z-0661-2019
Product Description
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 27,250 units total
- Distribution
- 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
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090. Recalled by ICU Medical, Inc.. Units affected: 27,250 units total.
Why was this product recalled? ▼
Potential for leakage due to defect in the thermoset check valve component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0661-2019.
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