--- title: "6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... — FDA record Z-1723-2022 | Is It on Recall" description: "Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing." url: https://isitonrecall.com/recall/fda-device-z-1723-2022-6-5-in-17-cm-appx-0-78-ml-ext-set-w-clave-clear-clave-4-way-stopcock-spiros-red-cap-accessory-for-in/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascula... — FDA record Z-1723-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set. - **Reason**: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. - **Classification**: Class II - **Recalling firm**: ICU Medical, Inc. - **Quantity**: Total of all affected units = 5,795,989 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1723-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1723-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution 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. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1723-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [ICU Medical, Inc. records](https://isitonrecall.com/brand/icu-medical-inc/)