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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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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
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Haemonetics Cymbal Automated Blood Collection Model LN1900 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 Class III Apheresis Collection Devices, with a possible pump encoder failure, were distributed. 93 units B-2194-12
Haemonetics MCS+9000 Pump Encoder Automated Blood Cell Separator Model LN 9000 Serial Numbers: 00A124-1 00F002-1 00F003 00F046-1 00F047-1 01M260 01M264 01 M265-1 01M279-2 01M282-2 02B151-2 02B155-2 02B156-2 02B157-2 02B160-3 02C033-3 02C036-3 02C037-3 02M202-1 02M203-1 03E020 03E021 03E075 03E076 03F089 04J033 04K025 04K026 04M080 04M081 04M082 05C014 05D056 05F064-1 05G101 05G103 05K067-1 06A297 06B355 06B357-1 06C075-1 06C076-1 06C361-1 06C362-1 06C363-1 06G004 06G005 06G006 06G008 06L117 06L118 06L119 07E194 07E195 07E269 07E270 07E271 07E274-1 07H336 07H340 07J101 07J102 07J103 07J179 07J180 07J190 07J192 07J297 08A325 08A326 08A327 08A328 08A345 08A348 08J142 08J143 08J144 08J408 08J409 08J410 08J411 08J412 08J498 08K030 08K031 08K033 08K034 09B093 09B294 09B295 09B296 09B297 09B298 09B299 09B300 09B301 09B302 09C056 09C057 09C058 09C059 09C060 09C167 09C168 09C169 94A124-MC+9 94A 127 -MC+9 94A 129-MC+9 94A130-1 94A135U-1 94A 138-MC+9 94A 139-MC+9 94A 146U-MC+ 94A147-MC+9 94A 149U-MC+ 94A151 U-MC+ 94A 152U-MC+ 94A 154-MC+9 94F275-MC+9 94F276-MC+9 94F290-MC+9 94F291-MC+9 95M039-MC+9 95M040-MC+9 95M041-MC+9 95M042-MC+9 95M043-MC+9 95M044-MC+9 95M081-MC+9 95M082-MC+9 95M083-MC+9 95M085-MC+9 95M086-MC+9 95M170U-MC-t 95M173U 95M174-MC+9 95M175-MC+9 95M177-MC+9 95M182U-1 95M191-MC+9 95M192-MC+9 95M194-MC+9 95M196U 95M198-MC+9 95M200-MC+9 96A044U-MC+ 96A045-MC+9 96A220-MC+9 96A221-MC+9 96A222-MC+9 96A223U-MC+ 96A225U-MC+ 96A226-MC+9 96B042-MC+9 96B043 96B044 96B046-MC+9 96B047-MC+9 96C078-MC+9 96C079-MC+9 96C195 96C370-MC+9 96C372-MC+9 96C373-MC+9 96C374U-MC+ 96C375-MC+9 96C376-MC+9 96C378-MC+9 96C380-MC+9 96C381-MC+9 96C478-MC+9 96C479-MC+9 96C484-MC+9 96C485 96D003-MC+9 96D004-MC+9 960008U 960099-MC+9 960101-MC+9 960102-MC+9 96D103-MC+9 96D104-MC+9 96D105-MC+9 96E041-MC+9 96E042-MC+9 96E042U 96E043-MC+9 96E044-MC+9 96E044U 96E045-MC+9 96E046-MC+9 96E047-MC+9 96E048-MC+9 96E049-MC+9 96E050-MC+9 96E051-MC+9 96E052-MC+9 96E053-MC+9 96E054-MC+9 96E207-MC+9 96E208-MC+9 96E209-MC+9 96E210-MC+9 96E323-MC+9 96E324U-MC+ 96F056-MC+9 96F059 96F068 96F092-MC+9 96F093-MC+9 96F095U-MC+ 96F097 96F097 -MC+9 96F097U 96F098-MC+9 96F105-MC+9 96F270-MC+9 96F271-MC+9 96F272-MC+9 96F273-MC+P 96F276-MC+9 96F278-MC+9 96F279-MC+9 96F280-MC+9 96F281-MC+9 96F283-MC+9 96F414-MC+9 96F415-MC+9 96F416-MC+9 96F418-MC+9 96F420-MC+9 96F422-MC+9 96F424-MC+9 96F425-MC+9 96F579-MC+9 96F580-MC+9 96F583-MC+9 96F584-MC+9 96F585-MC+9 96F586-MC+9 96F587 -MC+9 96F588-MC+9 96G103-MC+9 96G104-MC+9 96G106-MC+9 96G107-MC+9 96G108-MC+9 96K073-MC+9 96K074-MC+9 96K076-MC+9 96K077 -MC+9 96K078-MC+9 96K170-MC+9 96K171-MC+ 96K175C-1 96K176C-1 96K182U-MC+ 96K184-MC+9 96K185-MC+9 96K186U 96K188U 96L252-MC+9 96L339-MC+9 96L340-MC+9 96L341-MC+9 96L343-MC+9 96L426-MC+9 96L430U 96L432-MC+9 96L433 96M041-MC+9 96M042-MC+9 96M046-MC+9 96M047-MC+9 96M048-MC+9 96M049-MC+9 96M421-MC+9 96M425-MC+9 96M427 -MC+9 96M428-MC+9 96M429-MC+9 96M436-MC+9 96M437 -MC+9 96M438-MC+9 97B037 -MC+9 97B038-MC+9 97B040-MC+9 97B041-MC+9 97B042-MC+9 97B043-MC+9 97B204-MC+9 97B206-MC+9 97B320-MC+9 97B326-MC+9 97B326U-2 97B327 -MC+9 97B384-MC+9 97B386-MC+9 97B388-MC+9 97B389-MC+9 97B391-MC+9 97B392-MC+9 97D108-MC+9 97D109-MC+9 97D109U-2 97D112U-1 97D114U-MC+ 97D408-MC+9 97EOO1-MC+ 97E001U 97E006-MC+9 97E008-MC+9 97E009-MC+9 97E494-MC+9 97E499-MC+9 97E500-MC+9 97E501-MC+9 97F099-MC+9 97F174-MC+9 97F175-MC+9 97F177 -MC+9 97F178-MC+9 97F179-MC+9 97F265-MC+9 97F266-MC+9 97F267 -MC+9 97F268-MC+9 97F271 U-1 97F272-MC+9 97F273-MC+9 97F275-MC+9 97J130-MC+9 97J131-MC+9 97 J 132-MC+9 97 J 134-MC+9 97 J 135-MC+9 97 J 136-MC+9 97 J 185-MC+9 97 J 186-MC+9 97J191-MC+9 97 J192-MC+9 97 J222-MC+9 97 J223-MC+9 97 J224-MC+9 97 J225-MC+9 97J227-1 97 J228-MC+9 98C134-MC+9 98F128-MC+9 98F129-MC+9 98F136U 98H043 98H044-MC+9 98H046-MC+9 98H112-MC+9 98H113-MC+9 98H114-MC+9 98H115-MC+9 98H116-MC+9 98H117-MC+9 98H118 99L136 99L137 99L 139-MC+9 Class III Apheresis Collection Devices, with a possible pump encoder failure, were distributed. 372 units B-2193-12