MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravas...
FDA Device Recall #Z-1719-2022 — Class II — August 1, 2022
Recall Summary
| Recall Number | Z-1719-2022 |
| 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. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
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: MC100 UDI Code: 01108877090371581726110130100105716986 01108877090371581726110130100105716988 01108877090371581726110130100105716989 01108877090371581726110130100105716990 01108877090371581726110130100105716992 01108877090371581726110130100105716993 01108877090371581726110130100105716994 01108877090371581726120130100105737649 01108877090371581726120130100105737651 01108877090371581726120130100105739477 01108877090371581726120130100105739478 01108877090371581726120130100105739482 01108877090371581726120130100105739484 01108877090371581726120130100105739493 01108877090371581726120130100105755652 01108877090371581726120130100105757425 01108877090371581726120130100105757426 01108877090371581727010130100105771936 01108877090371581727010130100105771950 01108877090371581727010130100105771956 01108877090371581727010130100105786565 01108877090371581727010130100105815050 Lot Numbers: 5716986 5716988 5716989 5716990 5716992 5716993 5716994 5737649 5737651 5739477 5739478 5739482 5739484 5739493 5755652 5757425 5757426 5771936 5771950 5771956 5786565 5815050 Product Number: 12512-01 UDI Codes: 01108877090505391726120130100105724458 01108877090505391726120130100105736445 01108877090505391726120130100105739485 01108877090505391726120130100105739486 01108877090505391726120130100105739487 01108877090505391726120130100105739488 01108877090505391726120130100105754899 01108877090505391727010130100105771934 01108877090505391727010130100105793264 01108877090505391727010130100105798239 01108877090505391727010130100105802842 01108877090505391727020130100105812522 Lot Numbers: 5724458 5736445 5739485 5739486 5739487 5739488 5754899 5771934 5793264 5798239 5802842 5812522 Product Number: MC100-PR UDI Code: 01108877090372021726120130100105738352 Lot Number 5738352 Product Number: MC330446 UDI Code: 0110887709089096172612013050105746457 Lot Number: 5746457 Product Number: MC330545 UDI Code: 0110887709093222172701013050105773182 Lot Number: 5773182
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.