FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
- Recall number
- Z-0783-2007
- Recalling firm
- B. Braun Medical, Inc.
- Product
- B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
- Status
- Terminated
- Initiated
- 2007-04-11
- Posted
- 2007-05-05
- Terminated
- 2007-08-07
- Reason
- The integrity of the sterile product barrier may be compromised
- Root cause
- Other
- Action
- An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.
- Quantity
- 180 units
- Distribution
- Nationwide distribution --- including states of GA, MA, OH, and TX
- Lot, serial or model codes
- Lot number 0060911602
- 510(k) numbers
- ["K905201"]
- PMA numbers
- not on file
- Product code
- LHI
- 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