FDA Medical Device Recalls (openFDA)
Hsmg, Inc. D/b/a Smartinfuser Usa: SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
- Recall number
- Z-1022-2010
- Recalling firm
- Hsmg, Inc. D/b/a Smartinfuser Usa
- Product
- SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
- Status
- Terminated
- Initiated
- 2009-01-08
- Posted
- 2010-03-08
- Terminated
- 2011-04-25
- Reason
- Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
- Root cause
- Process control
- Action
- SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
- Quantity
- 444 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- All models and lot codes received 1/1/2007 to 1/22/2009. Part numbers P49524, P49534, P49624, and P49634.
- 510(k) numbers
- ["K072053"]
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 3004960040
- Firm city
- Houston
- Firm state
- TX
- 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