ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per…
- Recall date
- October 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0662-2019
- FDA classification
- Class II
- Brand / firm
- ICU Medical, Inc.
- Sold / distributed
- 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
Why it was recalled
Potential for leakage due to defect in the thermoset check valve component.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Get recall alerts
Free email alert whenever ICU Medical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: ICU Medical, Inc.