FDA Device recall Z-2816-2018
6" Smallbore Ext Set w/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 6" Smallbore Ext Set w/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-2816-2018 |
| 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
6" Smallbore Ext Set w/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 AM6130. a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Ex…Item Number AM6130. a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Expiration Date 02/01/2022; b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022; b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, 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-2816-2018%22
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