FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
- Recall number
- Z-0035-2007
- Recalling firm
- Haemonetics Corporation
- Product
- SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
- Status
- Terminated
- Initiated
- 2006-07-28
- Posted
- 2006-10-12
- Terminated
- 2006-10-24
- Reason
- Faulty circuit board may short circuit and cause electric shock to operator
- 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
- 15 units
- Distribution
- AZ, CT, GA, NE, MS Austria, France, Taiwan
- Lot, serial or model codes
- Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
- 510(k) numbers
- ["K052626"]
- PMA numbers
- not on file
- Product code
- BTA
- Firm FEI
- 1219343
- Firm city
- Braintree
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28