FDA Medical Device Recalls (openFDA)
ICU Medical de Mexico, S.A. de C.V.: 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.
- Recall number
- Z-2811-2018
- Recalling firm
- ICU Medical de Mexico, S.A. de C.V.
- 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.
- Status
- Terminated
- Initiated
- 2018-03-01
- Posted
- not on file
- Terminated
- 2024-01-26
- 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.
- 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 recall@icumed.com.
- Quantity
- 100 pouches
- Distribution
- US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K964435"]
- PMA numbers
- not on file
- Product code
- FMG
- Firm FEI
- 3003807466
- Firm city
- Mexico
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28