Severity
Moderate
FDA Devices recall · Reported July 19, 2017
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Icu Medical, Inc. recalled Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single us… - a moderate-severity action.
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single us… was recalled by Icu Medical, Inc. in July 19, 2017. Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.. Check the official notice for the remedy. Verify recall #Z-2721-2017 with the FDA Devices before acting.
The recall
Icu Medical, Inc. issued this moderate-severity FDA Devices recall-The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2721-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2721-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on May 30, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Icu Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records list the affected scope as 100 units.
The documented reason for this recall is: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Distribution data in the federal record shows the product reached: Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
100 units
Related Recalls
6
0 from same agency
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2721-2017 |
| Date reported | July 19, 2017 |
| Date initiated | May 30, 2017 |
| Recalling firm | Icu Medical, Inc. |
| Firm location | San Clemente, CA |
| Affected scope | 100 units |
| Distribution | Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 19, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.