FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. For use with Secondary Container.
- Recall number
- Z-1433-2009
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. For use with Secondary Container.
- Status
- Terminated
- Initiated
- 2009-03-27
- Posted
- 2009-06-05
- Terminated
- 2009-12-15
- Reason
- Device defect is occlusion/no flow.
- 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
- 52,050 units
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Lot #'61030997 with an expiration date of 12/31/2013 and Lot #'s 61031000, 61031001, 61031002, and 61031004 with an expiration date of 1/31/2014.
- 510(k) numbers
- ["K790062","K955585"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- 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