Z-0035-2007

SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

Name: Z-0035-2007 SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Creator: Haemonetics Corporation
Published: 2006-07-28
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2006-07-28 / Terminated

FDA source

Haemonetics Corporation began a recall of SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US on 2006-07-28. The reason FDA records is "Faulty circuit board may short circuit and cause electric shock to operator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0035-2007
Status: Terminated
Initiated: 2006-07-28
Posted: 2006-10-12
Terminated: 2006-10-24
Recalling firm: Haemonetics Corporation
Product: SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Faulty circuit board may short circuit and cause electric shock to operator
FDA root cause: Other
Action: Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.
Quantity in commerce: 15 units
Distribution: AZ, CT, GA, NE, MS Austria, France, Taiwan
Product codes and lots: Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248

Product code BTA

K052626Class IISmartsuction Harmony DeviceHaemonetics Corp. / cleared 2005-10-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)