FDA Medical Device Recalls (openFDA)
Hsmg, Inc. D/b/a Smartinfuser Usa: SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.
- Recall number
- Z-1981-2011
- Recalling firm
- Hsmg, Inc. D/b/a Smartinfuser Usa
- Product
- SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.
- Status
- Terminated
- Initiated
- 2010-03-17
- Posted
- 2011-04-14
- Terminated
- 2011-04-25
- Reason
- Elastomeric tube in product's compression unit has the potential to burst following filling.
- Root cause
- Other
- Action
- Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.
- Quantity
- 368 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot numbers: 1051003, 11051004, 11051005, 1052004, 10052005, 11052006, 1053002, and 1054002.
- 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