FDA Enforcement
Class II
Terminated
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.
Recall: Z-1076-2016
·
Reported March 16, 2016
Enforcement
- Recall Number
- Z-1076-2016
- Event ID
- 73008
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 16, 2016
- Initiation Date
- December 9, 2015
- Classification Date
- March 8, 2016
- Termination Date
- January 9, 2017
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
Description
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.
Reason
The sterility of the product cannot be assured. This may result in increased risk of infection.
Code Info
Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
Distribution
US Distribution to:California and Utah.
Quantity
250 units