FDA Device recall Z-0213-2021
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer by Icu Medical, citing identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoCl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0213-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-06 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
Reason
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Identifiers
| code_info | Lot Numbers:4493459, 4536673. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0213-2021%22
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