FDA Device recall Z-2815-2018
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valv…
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valv… 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-2815-2018 |
| 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
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), 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 AM6128. a. Lot Number 3423330, UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330, Ex…Item Number AM6128. a. Lot Number 3423330, UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330, Expiration Date 04/01/2022; b. Lot Number 3476737, UDI Number (01) 1 0887709 08696 5 (17) 220601 (30) 50 (10) 3476737, Expiration Date 06/01/2022 |
|---|
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-2815-2018%22
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