FDA Device recall Z-2806-2018
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear by Icu Medical De Mexico, citing ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2806-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-01 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical De Mexico |
| Distribution | AZ, MA, NC, OH, TX, VA, WA |
Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Reason
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Identifiers
| code_info | Item Number 011-AM6123. a. Lot Number 3393136, UDI Number (01) 1 0840619 09404 8 (17) 220101 (30) 20 (10) 3393136,…Item Number 011-AM6123. a. Lot Number 3393136, UDI Number (01) 1 0840619 09404 8 (17) 220101 (30) 20 (10) 3393136, Expiration Date 11/01/2022; b. Lot Number 3508527, UDI Number (01) 1 0840619 09404 8 (17) 220801 (30) 20 (10) 3508527, Expiration Date 08/01/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2806-2018%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.