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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Haemonetics Cymbal Automated Blood Collection Model LN1900
Recall Number B-2194-12
Classification Class III
Code Info Serial Numbers: 07A180-1 07M111 06A252U-1 07B115-1 06A255 06K067-1 07B209-1 06K066-1 07B104-1 07B208-1 08K224 08K227 08K260 08K226 07B114-1 07B117-1 07B192-1 07A181-1 07A182-1 07B110-1 07B193-1 07M108 07M085 07M105 07M107 07M109 07M110-1 07M112 07M113 07B105U-1 07A172-1 07B109-1 06K075-1 07A178-1 07A183-1 07B200-1 07B206-1 07M341-1 07M342-1 07B211-1 07L040 07A175-1 07L183 06A261U-1 07A184-1 07B108-1 07B106-1 08K225 07M117 08K223 08K255 07M118 08K258 07M116 08K254 08K256 08K257 08K259 07M114 07B204-1 07A174-1 07B111-1 06K070-1 07L032 07C302-1 06K080-1 06K064-1 07M115 07B210-1 07M106-1 06K063-2 06K068-1 06K069-1 07B194-1 07B202-2 07B201-1 07B191-1 07B113-1 07B195-1 07B116-1 07B189-1 07A179-1 07B203-1 07B112-1 07B205-1 07B207-1 06K072-1
Product Distributed Qty 93 units
Reason For Recall Apheresis Collection Devices, with a possible pump encoder failure, were distributed.

Event Detail

Event Id 61150
Product Type Biologics
Status Terminated
Recalling Firm Haemonetics Corporation
City Braintree
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-08-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide