8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear,...
FDA Device Recall #Z-1720-2022 — Class II — August 1, 2022
Recall Summary
| Recall Number | Z-1720-2022 |
| 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
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
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: 12517-01 UDI Code: 0110887709047201172612013050105735675 0110887709047201172612013050105755784 0110887709047201172612013050105755788 0110887709047201172702013050105812525 Lot Numbers: 5735675 5755784 5755788 5812525 Product Number: A1099 UDI Codes: 0110887709053127172611013050105692378 Lot Numbers: 5692378 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: A1132 UDI Code: 0110887709068350172701013050105772482 Lot Number: 5772482 Product Number: A1152 UDI Code: 0110887709071527172612013050105735432 0110887709071527172701013050105787700 Lot Number: 5735432 5787700 Product Number: MC330113 UDI Codes: 0110887709078120172612013050105746371 0110887709078120172612013050105755711 0110887709078120172701013050105789359 Lot Numbers: 5746371 5755711 5789359 Product Number: MC330246 UDI Codes: 0110887709081502172610013050105641882 0110887709081502172612013050105738474 0110887709081502172701013050105773798 0110887709081502172701013050105788509 0110887709081502172701013050105809713 Lot Numbers: 5641882 5738474 5773798 5788509 5809713 Product Number: MC330247 UDI Codes: 0110887709081519172612013050105745619 0110887709081519172612013050105756766 0110887709081519172701013050105777168 0110887709081519172701013050105789411 Lot Numbers: 5745619 5756766 5777168 5789411 Product Number: MC33056 UDI Code: 0110887709037301172701013050105772683 Lot Number: 5772683 Product Number: MC330605 UDI Code: 0110887709097008172701013050105789539 Lot Number: 5789539 Product Number: MC33122 UDI Codes: 0110887709037400172612013050105757061 0110887709037400172701013050105772640 0110887709037400172701013050105788745 Lot Numbers: 5757061 5772640 5788745 Product Number: MC33213 UDI Codes: 0110887709037516172612013050105736601 0110887709037516172701013050105789780 0110887709037516172701013050105789784 Lot Numbers: 5736601 5789780 5789784 Product Number: MC33326 UDI Codes: 0110887709037752172612013050105757376 0110887709037752172701013050105772627 0110887709037752172701013050105772638 0110887709037752172702013050105810377 Lot Numbers: 5757376 5772627 5772638 5810377 Product Number: MC33600 UDI Code: 0110887709051932172701013050105789950 Lot Number: 5789950 Product Number: MC33729 UDI Codes: 0110887709065045172701013050105789984 0110887709065045172701013050105800993 Lot Numbers: 5789984 5800993 Product Number: MC33786 UDI Code: 0110887709067551172701013050105778247 Lot Number: 5778247 Product Number: Z3419 UDI Code: 0110887709032108172612013050105754551 Lot Number: 5754551 Product Number: Z3678 UDI Codes: 0110887709034607172612013050105754702 0110887709034607172701013050105777801 Lot Numbers: 5754702 5777801
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.