FDA Device recall 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 intravascular administration set
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of 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 by Icu Medical, citing due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1723-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-01 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Icu Medical |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
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.
Identifiers
| code_info | Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1723-2022%22
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