Tego Connector — Class II medical device recall Z-0988-2017
Terminated recall by ICU Medical, Inc., reported 2017-01-18, distributed nationwide. ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
| Recall number | Z-0988-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2017-01-10 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, BR, CA, CH, DE, EE, FR, GB, IE, IT, LU, MY, NL, PL, PT, SA, SE, SI |
| Quantity | 476,600 units |
| Reason classes | packaging |
| Model numbers | D1000, NM1000 |
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.
Reason for recall
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0988-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.