FDA Device recall Z-0263-2021
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of NanoClave Connector. 1 unit per pouch, 100 multivac 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-0263-2021 |
| 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
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the 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:4559476, 4711354, 4476111, 4493213, 4510900, 4749152. |
|---|
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-0263-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.