Z-1428-2009

Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3...

Name: Z-1428-2009 Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3...
Creator: B. Braun Medical, Inc.
Published: 2009-03-27
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2009-03-27 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and... on 2009-03-27. The reason FDA records is "Device defect is occlusion/no flow". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1428-2009
Status: Terminated
Initiated: 2009-03-27
Posted: 2009-06-05
Terminated: 2009-12-15
Recalling firm: B Braun Medical Inc
Product: Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Device defect is occlusion/no flow.
FDA root cause: Mixed-up of materials/components
Action: An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.
Quantity in commerce: 13,008 units
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: Lot #'s 61040841 (exp 2/28/2012) and 61040842 (exp 1/31/2012).

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)