FDA Device recall Z-2811-2018
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcoc…
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcoc… 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-2811-2018 |
| 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
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
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-AM6133. a. Lot Number 3493948, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3493948,…Item Number 011-AM6133. a. Lot Number 3493948, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3493948, Expiration Date 07/01/2022; b. Lot Number 3498107, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3498107, Expiration Date 07/01/2022 |
|---|
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-2811-2018%22
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