MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Co...

FDA Device Recall #Z-1722-2022 — Class II — August 1, 2022

Recall Summary

Recall Number Z-1722-2022
Classification Class II — Moderate risk
Date Initiated August 1, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical, Inc.
Location San Clemente, CA
Product Type Devices
Quantity Total of all affected units = 5,795,989 units

Product Description

MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set

Reason for Recall

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

Distribution Pattern

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.

Lot / Code Information

Product Number: 011-MC100 UDI Code: 01108406190425061726120130100105737404 01108406190425061726120130100105740700 01108406190425061726120130100105740701 01108406190425061726120130100105740702 01108406190425061726120130100105740703 01108406190425061726120130100105740705 01108406190425061726120130100105740706 01108406190425061726120130100105740707 01108406190425061726120130100105740708 01108406190425061726120130100105740712 01108406190425061726120130100105740713 01108406190425061726120130100105740714 01108406190425061726120130100105740715 01108406190425061726120130100105740719 01108406190425061726120130100105740721 01108406190425061727010130100105793254 01108406190425061727010130100105793255 01108406190425061727010130100105793259 Lot Numbers: 5737404 5740700 5740701 5740702 5740703 5740705 5740706 5740707 5740708 5740712 5740713 5740714 5740715 5740719 5740721 5793254 5793255 5793259 Product Number: MR4001 UDI Codes: 01108877090796081726120130100105738132 Lot Numbers: 5738132 Product Number: MS984 UDI Code: 01108424721008291726120130100105737492 Lot Number 5737492 Product Number: SC3000 UDI Code: 01108877090818301726120130100105726857 01108877090818301726120130100105753967 Lot Number: 5726857 5753967

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.