Device product
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.
Z-2285-2018
Product summary
- Event
- Event 80142
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,872
- Official record key
device-enforcement:Z-2285-2018
Official wording
Reason: There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
Code information: Lot Number: 0061583973
Distribution pattern: US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
Derived failure modes
-
Unknown
There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.