FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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 number
- Z-1076-2016
- Recalling firm
- Becton Dickinson & Company
- 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.
- Status
- Terminated
- Initiated
- 2015-12-09
- Posted
- 2016-03-08
- Terminated
- 2017-01-09
- Reason
- The sterility of the product cannot be assured. This may result in increased risk of infection.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 250 units
- Distribution
- US Distribution to:California and Utah.
- Lot, serial or model codes
- Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
- 510(k) numbers
- ["K141474"]
- PMA numbers
- not on file
- Product code
- PHC
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28