—#142710

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.

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K141474
Affected lot / code info: Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.

Why it was recalled

The sterility of the product cannot be assured. This may result in increased risk of infection.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Distribution to:California and Utah.

Timeline

Recall initiated: 2015-12-09
Posted by FDA: 2016-03-08
Terminated: 2017-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142710. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.