SmartSuction Harmony Powered Suction Device recallZ-0035-2007 · Haemonetics Corporation · initiated Jul 28, 2006
Terminated All recalls posted in October 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Haemonetics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Faulty circuit board may short circuit and cause electric shock to operator
FDA root cause category: Other
What the company is doing
Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.
Recall details
- Recall number
- Z-0035-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 28, 2006
- Posted by the FDA
- Oct 12, 2006
- Recalling firm
- Haemonetics Corporation
- Quantity
- 15 units
- Product code
- BTA
- FDA submissions
- K052626
- Distribution
- AZ, CT, GA, NE, MS Austria, France, Taiwan
Product description
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Code information (models, lots, serial numbers)
Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
Other devices under the same FDA submission
1 device cleared under K052626 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HAEMONETICS SMARTSUCTION TECHNOLOGY HAR-A-1000Haemonetics Corporation · Pump, Portable, Aspiration (Manual Or Powered)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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