FDA Device Entity Profile: Haemonetics Corporation

Known Identifiers & Locations

FEI Numbers 1219343, 3003327833, 3011538588, 3011773324, 3019849102

Owner Operator Numbers 1219343

Locations Covered Boston, MA, US; Clinton, PA, US; Penang Pulau Pinang, MY; Salt Lake City, UT, US; TIJUANA, B.C. Mexico, MX

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1219343	HAEMONETICS CORPORATION	Boston, MA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3011538588	Haemonetics Malaysia Sdn Bhd	Penang Pulau Pinang, MY	Manufacture Medical Device	View Details
3011773324	Haemonetics Corporation	Salt Lake City, UT, US	Manufacture Medical Device	View Details
3019849102	Haemonetics Corporation	Clinton, PA, US	Manufacture Device in the United States for Export Only	View Details
9617787	Haemonetics Mexico Manufacturing S. de R.L. de C.V.	TIJUANA, B.C. Mexico, MX	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0035-2007	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US Reason: Faulty circuit board may short circuit and cause electric shock to operator	2006-07-28	Terminated	View Details

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