FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
- Recall number
- Z-0500-2020
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
- Status
- Terminated
- Initiated
- 2019-10-14
- Posted
- not on file
- Terminated
- 2020-10-16
- Reason
- Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
- Root cause
- Packaging process control
- Action
- BD issued notifications to Customers via FedEx to Distributors, Pharmacies, and Consumers via Pharmacies on 10/14/19, advising of the problem, health risk and action to take: Immediately review your inventory for the specific Catalog and Lot number listed , discontinue use and destroy all product subject to the recall following your institutions process for destruction.2. Complete the Customer Recall Response Form. Questions or require further assistance, please contact 1-888-731-7973 between 8 AM and 5 PM ET Monday through Friday.
- Quantity
- 967,680
- Distribution
- Distribution US Nationwide and Canada
- Lot, serial or model codes
- Lot Number: 9175971 UDI: 50382903065757
- 510(k) numbers
- ["K161552"]
- PMA numbers
- not on file
- Product code
- NGT
- 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