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 Inc. has identified a potential risk of leaking with certain Tego Connector devices. |
| Product | Tego Connector, Item No. D1000, NM1000 The Tego® Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego® is a needle-free capping device which closes the end of the catheter. The Tego® will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries. |
| Quantity | 476,600 units |
| Distribution | Worldwide Distribution-US: (Nationwide) and countries of: Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Great Britain, France, Brazil, Sweden, Slovenia, and Portugal. |
| Initiated | 2016-08-24 |
| Classified | 2017-01-10 |
| Terminated | 2017-07-07 |
| Recall number | Z-0988-2017 |
| 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-0988-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75093/
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