Z-2805-2018Class II

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings)...

Name: Z-2805-2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings)...
Creator: ICU Medical de Mexico, S.A. de C.V.
Published: 2018-03-01
License: https://open.fda.gov/license/

ICU MEDICAL de MEXICO, S. de R.L. de C.V. / initiated 2018-03-01 / Terminated

FDA source

ICU Medical de Mexico, S.A. de C.V. began a recall of PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer on 2018-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2805-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-01
Posted: 2018-08-16
Terminated: 2024-01-26
Recalling firm: ICU MEDICAL de MEXICO, S. de R.L. de C.V.
Product: PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Product code: FMG Stopcock, I.V. Set
Reason for recall: 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.
FDA root cause: Other
Action: ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to [email protected].
Quantity in commerce: 532 pouches
Distribution: US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2805-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2797-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2798-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2799-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2800-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2801-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2802-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2803-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2804-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2805-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2806-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2807-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2808-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2809-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2810-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2811-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2812-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2813-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2814-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2815-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2816-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)