FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
- Recall number
- Z-2717-2017
- Recalling firm
- ICU Medical, Inc.
- Product
- 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
- Status
- Terminated
- Initiated
- 2017-05-30
- Posted
- 2017-06-26
- Terminated
- 2024-09-20
- Reason
- The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: Productreturns@icumed.com.
- Quantity
- 120 units
- Distribution
- Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
- Lot, serial or model codes
- Lot No. 3297341, 3354442, 3388890. Item No. 011-AM6115
- 510(k) numbers
- ["K964435"]
- PMA numbers
- not on file
- Product code
- FMG
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- 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