Device product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
Z-2815-2018
Product summary
- Event
- Event 80460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 pouches
- Official record key
device-enforcement:Z-2815-2018
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 AM6128. a. Lot Number 3423330, UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330, Expiration Date 04/01/2022; b. Lot Number 3476737, UDI Number (01) 1 0887709 08696 5 (17) 220601 (30) 50 (10) 3476737, Expiration Date 06/01/2022
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.