Device product
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
Z-1076-2016
Product summary
- Event
- Event 73008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 units
- Official record key
device-enforcement:Z-1076-2016
Official wording
Reason: The sterility of the product cannot be assured. This may result in increased risk of infection.
Code information: Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
Distribution pattern: US Distribution to:California and Utah.
Derived failure modes
-
Unknown
The sterility of the product cannot be assured. This may result in increased risk of infection.