Z-1982-2011

SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD

Name: Z-1982-2011 SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD
Creator: Hsmg, Inc. D/b/a Smartinfuser Usa
Published: 2010-03-17
License: https://open.fda.gov/license/

Hsmg, Inc. D/b/a Smartinfuser USA / initiated 2010-03-17 / Terminated

FDA source

Hsmg, Inc. D/b/a Smartinfuser Usa began a recall of SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD on 2010-03-17. The reason FDA records is "Elastomeric tube in product's compression unit has the potential to burst following filling". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1982-2011
Status: Terminated
Initiated: 2010-03-17
Posted: 2011-04-14
Terminated: 2011-04-25
Recalling firm: Hsmg, Inc. D/b/a Smartinfuser USA
Product: SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Elastomeric tube in product's compression unit has the potential to burst following filling.
FDA 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 in commerce: 1,483 units
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers: 1011004, 11011005, 1012004, 11012005, 11012006, 11012007, 11012008, 11042002, 11042003, 11014002, and 11044001.

Product code MEB

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)