Hsmg, Inc. D/b/a Smartinfuser Usa SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
Brand
Hsmg, Inc. D/b/a Smartinfuser Usa
Lot Codes / Batch Numbers
All models and all lot codes in the USA received 1/1/2007 through 1/22/2009.
Products Sold
All models and all lot codes in the USA received 1/1/2007 through 1/22/2009.
Hsmg, Inc. D/b/a Smartinfuser Usa is recalling SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. due to Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
Recommended Action
Per FDA guidance
SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026