Device product
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.
Z-0980-2017
Product summary
- Event
- Event 75895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 units
- Official record key
device-enforcement:Z-0980-2017
Official wording
Reason: ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
Code information: Lot No. 3323650
Distribution pattern: US: NC
Derived failure modes
-
Unknown
ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.