FDA Device recall Z-2814-2018
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer 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-2814-2018 |
| 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
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
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 AM6127. a. Lot Number 3379607, UDI Number (01) 1 0887709 08635 4 (17) 211201 (30) 50 (10) 3379607, Ex…Item Number AM6127. a. Lot Number 3379607, UDI Number (01) 1 0887709 08635 4 (17) 211201 (30) 50 (10) 3379607, Expiration Date 12/01/2021; b. Lot Number 3436226, UDI Number (01) 1 0887709 08635 4 (17) 220401 (30) 50 (10) 3436226, Expiration Date 04/01/2022 |
|---|
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-2814-2018%22
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