FDA Device recall Z-2805-2018
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), 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-2805-2018 |
| 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
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), 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 011-AM6118. a. Lot Number 3358780, UDI Number (01)01 0840619 09319 (17) 211101 (30) 50 (10) 3358780, E…Item Number 011-AM6118. a. Lot Number 3358780, UDI Number (01)01 0840619 09319 (17) 211101 (30) 50 (10) 3358780, Expiration Date 11/01/2021; b. Lot Number 3365174, UDI Number (01) 01 0840619 09319 5 (17) 211101 (30)50 (10) 3365174, Expiration Date 11/01/2021; c. Lot Number 3367857, UDI Number (01) 01 0840619 09319 8 (17) 211101 (30) 01 (10) 3387857, Expiration Date 11/01/2021; d. Lot Number 3497708, UDI Number (01) 1 0840619 09319 5 (17) 220701 (30) 50 (10) 3497708, Expiration Date 07/01/2022; e. Lot Number 3508531, UDI Number (01) 1 0840619 09319 5 (17) 220801 (30) 50 (10) 3508531, Expiration Date 08/01/2022 |
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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-2805-2018%22
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