FDA Device Recall Z-0035-2007: Haemonetics Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2007.

Recall Res Number

Z-0035-2007

Recalling Firm / Manufacturer

Haemonetics Corporation

FEI Number

1219343

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-07-28

Date Posted

2006-10-12

Date Terminated

2006-10-24

Product Code

BTA

Event Number

36005

Product Quantity

15 units

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

Reason for Recall Faulty circuit board may short circuit and cause electric shock to operator

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

Distribution Pattern AZ, CT, GA, NE, MS Austria, France, Taiwan

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

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Medical Device Recall: Z-0035-2007

Recall Parameters & Description

Related Establishments / Registrations

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