Device product
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Z-2799-2018
Product summary
- Event
- Event 80460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 pouches
- Official record key
device-enforcement:Z-2799-2018
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-AM3003. a. Lot Number 3303902, UDI Number (01)1 0840519 09277 6 (17)210800 (30) 50 (10) 3303902, Expiration Date 08/01/2021; b. Lot Number 3380550, UDI Number (01) 1 0840619 09277 8 (17) 211201 (30) 50(10) 3380550, Expiration Date 12/01/2021
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.