FDA Medical Device Recalls (openFDA)
Hsmg, Inc. D/b/a Smartinfuser Usa: SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
- Recall number
- Z-1021-2010
- Recalling firm
- Hsmg, Inc. D/b/a Smartinfuser Usa
- Product
- SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
- 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
- 6,393 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- All models and all lot codes in the USA received 1/1/2007 through 1/22/2009.
- 510(k) numbers
- ["K061409"]
- 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