Recall Z-1076-2016
Becton Dickinson & Company · initiated December 9, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
Reason for recall
The sterility of the product cannot be assured. This may result in increased risk of infection.
FDA-determined cause: Under Investigation by firm
Action taken
Becton Dickinson representatives notified their customers in person and a copy of the "Urgent Product Recall" letter and "Recall Response Form" dated 12/9/2015 was provided. The letter identified the reason for the recall; how to identify affected product; and the actions to be taken. The letter instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-201-847-4267 it to BD or email it to Becky_Saggau@bd.com even if you do not have any of the affected lot; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-201-847-4267 between 8AM and 5 PM ET Monday through Friday.
Details
- Recall number
- Z-1076-2016
- Initiated
- December 9, 2015
- Posted by FDA
- March 8, 2016
- Terminated
- January 9, 2017
- Product code
- PHC – Infusion Safety Management Software
- Quantity
- 250 units
- Distribution
- US Distribution to:California and Utah.
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ