Recall Z-0035-2007

Haemonetics Corporation · initiated July 28, 2006

Terminated

Product

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

Codes / lots: Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248

Reason for recall

Faulty circuit board may short circuit and cause electric shock to operator

FDA-determined cause: Other

Action taken

Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.

Details

Recall number
Z-0035-2007
Initiated
July 28, 2006
Posted by FDA
October 12, 2006
Terminated
October 24, 2006
Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Quantity
15 units
Distribution
AZ, CT, GA, NE, MS Austria, France, Taiwan
Recalling firm
Haemonetics Corporation, Braintree, MA

Official FDA recall record