Z-1021-2010

SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234

Name: Z-1021-2010 SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234
Creator: Hsmg, Inc. D/b/a Smartinfuser Usa
Published: 2009-01-08
License: https://open.fda.gov/license/

Hsmg, Inc. D/b/a Smartinfuser USA / initiated 2009-01-08 / Terminated / root cause: manufacturing process

FDA source

Hsmg, Inc. D/b/a Smartinfuser Usa began a recall of SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234 on 2009-01-08. The reason FDA records is "Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1021-2010
Status: Terminated
Initiated: 2009-01-08
Posted: 2010-03-08
Terminated: 2011-04-25
Recalling firm: Hsmg, Inc. D/b/a Smartinfuser USA
Product: SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
Quantity in commerce: 6,393 units
Distribution: Nationwide.
Product codes and lots: All models and all lot codes in the USA received 1/1/2007 through 1/22/2009.

Product code MEB

K061409Class IISmartinfuser Painpump, Model P49220 W/catheter Set; P49224n W/o Catheter SetPrecise Medical Products, Ltd. / cleared 2006-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)