Class II — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr. |
| Product | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; 300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121; 3 Gang 3-Way Stopcocks w/R… |
| Quantity | 24,475 (17,225 in US) |
| Distribution | US Distribution and Internationally to TH. |
| Initiated | 2017-08-31 |
| Classified | 2017-11-17 |
| Terminated | 2018-10-17 |
| Recall number | Z-0106-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ICU Medical, Inc. (Z-0106-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78191/
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