FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)
- Recall number
- Z-2412-2008
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2008-09-23
- Terminated
- 2009-05-05
- Reason
- incorrect burette was packaged with the product
- Root cause
- Mixed-up of materials/components
- Action
- The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
- Quantity
- 2560 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number 60999546 exp 3/31/2013
- 510(k) numbers
- ["K781744","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
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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