FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton
- Recall number
- Z-1235-2007
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton
- Status
- Terminated
- Initiated
- 2007-07-30
- Posted
- 2007-09-20
- Terminated
- 2008-04-01
- Reason
- Particulate matter in product.
- Root cause
- Other
- Action
- The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.
- Quantity
- 33,240 units
- Distribution
- The products were shipped to distributors nationwide.
- Lot, serial or model codes
- Item number 531584. Lot number 070606SFR exp 6/09
- 510(k) numbers
- ["K002142"]
- PMA numbers
- not on file
- Product code
- NGT
- 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