NanoClave Connector — Class II medical device recall Z-0658-2014
Terminated recall by ICU Medical, Inc., reported 2014-01-15, distributed in AL, CA, GA, HI, IL, KY, NC, NH…. ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small pe
| Recall number | Z-0658-2014 |
|---|---|
| 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 | 2013-12-24 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-04-01 |
| Distributed | AL, CA, GA, HI, IL, KY, NC, NH, OH, TN, TX, UT, VT, WI |
| Quantity | 69,100 units |
| Reason classes | packaging |
| Lot numbers | 2766916, 2767054, 2767355, 2768331, 2770578, 2776455, 2781527, 2781554, 2783362, 2785375, 2787992, 34-463-HE |
| Model numbers | 011-A1000, 061-A1000, A1000, K7083-001, Z3769 |
Product
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Reason for recall
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
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-0658-2014. 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.