FDA Device recall Z-0236-2021
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case 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-0236-2021 |
| 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
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)50(10)4558614; (01)10887709067582(17)250201(30)50(10)4733732; (01)10887709067582(17)241201(30)50(10)4493665. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
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:4548270, 4558614, 4733732, 4493665. |
|---|
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-0236-2021%22
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