REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spir...

FDA Device Recall #Z-1570-2021 — Class II — March 16, 2021

Recall Summary

Recall Number Z-1570-2021
Classification Class II — Moderate risk
Date Initiated March 16, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical, Inc.
Location San Clemente, CA
Product Type Devices

Product Description

REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Reason for Recall

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Lot / Code Information

REF: CL3011 UDI: (01) 1 0887709 05701 9 (17) 260101 (30) 50 (10) 5125298 Lot Number: 5125298

Other Recalls from ICU Medical, Inc.

Recall # Classification Product Date
Z-1111-2026 Class II Tego Connector: REF: 011-D1000, 01C-D1000, 055-... Dec 19, 2025
Z-1094-2026 Class II Plum Duo Infusion System, List Number 40002-04-01 Dec 15, 2025
Z-1119-2026 Class II ICU Medical Plum Duo Precision IV Pump, List Nu... Dec 15, 2025
Z-1120-2026 Class II ICU Medical Plum Solo Precision IV Pump, List N... Dec 15, 2025
Z-1118-2026 Class II ICU Medical Plum Duo Infusion Pump, List Number... Dec 15, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.