FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. 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-2414-2008
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. 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
- 2960 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number 00VL987139 exp 12/31/2012
- 510(k) numbers
- ["K781744","K921860"]
- 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