Device product
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
Z-2797-2018
Product summary
- Event
- Event 80460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 pouches
- Official record key
device-enforcement:Z-2797-2018
Official wording
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.
Code information: Item Number 011-AM3002. a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021; b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022
Distribution pattern: US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Derived failure modes
-
Unknown
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.