| | Class 2 Recall
Belmont Rapid Infuser |  |
| Date Posted |
October 12, 2012 |
| Recall Number |
Z-0058-2013 |
| Product |
Belmont Rapid Infuser, a Fluid Management System,
Model FMS2000. |
| Code Information |
Serial Numbers:
2012012793
2012012808
2012012809
2012022821
2012022822
2012022855
2012032880
2012032881
2012032883
2012032885
2012032886
2012032887
2012032888
2012032891
2012032904
2012032906
2012032907
2012032908
2012032910
2012042942
2012042944
2012052946
2012052948
2012052958
M030139
"1003
Q050656
Q050657"
"2012012782
2012012783"
"2012012784
2012012785"
"2012012794
2012012795
2012012801
2012012802
2012012803
2012012805
2012022826"
"2012012810
U082129"
"2012022823
2012022824"
"2012022827
2012022828"
"2012022829
2012022830
2012022831
2012022832
2012022833
2012022834
2012022835"
"2012022847
2012022848"
"2012022849
2012022850
2012022851"
"2012022852
2012022853"
"2012032878
2012032879"
"2012032881
2012032882
U011950
T121937"
"2012032889
S121587"
"2012032894
V092579"
"2012032895
2012032902"
"2012032903
U032005"
"2012032908
2012032909
2012032911
2012042933"
"2012052952
2012052954"
J010005
J050006
J050008
J050009
"J050010
J060012
K110075
M010129
I120001
N030242
P010456"
"J060011
L080103
L110115
L110116
L110117"
J060013
"J060013
M090183"
"J060014
J080017"
"J060015
K070065
N080286
N090294
T111921
T111922"
"J060016
J080018
S021405
U092151"
J080019
"J120032
Q040631"
J120033
"J120038
J120039
U031995
U032000"
"K020045
K050053
K050055
K050056
K050060
K050061
K050062
N110310
O070386
O070385"
K020047
K020048
K020049
"K030050
L100105
L100107
L100108"
K050058
"K070067
K070069
N060278"
"K110074
J050007"
L030086
"L040087
L040092
P050500
K030052
R071010
S021358
T061693"
L040088
"L040089
L040090 "
"L040091
M070179"
"L050094
O070389
R091082"
"L050095
M070173 "
L080100
L100113
"M010128
M020133
P110573"
"M020136
S041422"
M030141
M030142
"M030146
M030147"
M030148
"M030149
S051444
U011943
U011944"
"M050164
M080181
P050495"
"M050165
M050166"
"M060168
O110437"
"M060169
M060170
V072487"
"M070171
M070172
R081041
U112182"
"M070174
O010334
T121936"
M070175
M070176
J110028
M090185
S061493
S061495
S081525
S091536
M110186
M120190
N040261
N040262
N040263
N040264
N060275
N040265
N050266
N050267
N120327
N120328
N060279
N060277
N060280
T031649
N080283
N100304
T061691
N090289
O080410
O090415
O090416
M010121
P050501
P050502
Q120789
N090290
O070380
N090292
N090293
N090295
N090297
N090299
N090298
K020046
N090300
N090296
N090301
O070381
N100303
Q040636
Q040637
N100306
N100307
R020837
T011614
U082125
N110309
N110312
O010330
O010331
O010332
Q040632
Q040633
Q040634
S021377
S021380
O010333
O090420
P100557
O010338
O010339
O020341
O010340
O020354
O020349
O020348
O020347
O020344
Q060679
O020355
O020356
O020359
Q120790
Q120791
O030360
O030366U
O030367U
P030472
U072109
O030369
P080540
R081027
R111172
O060375
O070376
O070382
U032016
V062428
O070384
V042334
O070387
P100556
Q120802
S061504
O070388
O070391
O070390
S021391
O070393
O070392
O070394
O080401
O080403
O080404
O080405
O080402
O080406
O080407
M030150
O010337
O080408
S051444
S051448
S121586
U092143
S101556
O080409
O090421
S011269
M020131
M050167
P110572
P030470
P050503
O100428
O110430
O110431
O110436
P030467
V012251
V012252
O110439
O120440
O120441
O120442
P010452
P010453
P010454
P010455
P010458
M020138
P020459
Q050651
Q120793
P030468
P030469
P030471
P030473
V102641
P050498
P050499
P050505
P050509
T111913
P060517
P080531
S101552
V102662
P080541
P080543
P100548
P100550
P100551
S051463
P100552
P120583
P120584
P100558
Q120781
Q120782
P100559
P110561
P110571
T031650
U092155
P120582
Q050638
Q090741
Q050639
Q050640
Q050650
R101152
S101568
Q050654
Q050659
V112667
Q050655
Q050658
O030362
O030365
N050268
Q060664
U072113
U072114
U072115
U082121
U082122
U082123
U082124
Q060665
S061494
S011281
Q070681
Q070682
M020132
M020135
M020137
K110076
K110079
K110080
K110081
K110082
P050496
L100110
L100111
L100112
L100114
L110118
L120119
Q070688
U021986
Q070689
Q070690
Q070691
J120034
J120036
Q090729
S121595
Q090730
Q090731
Q090732
S011254
S011265
Q090734
Q090733
Q090736
Q090735
Q090737
Q090739
Q090738
Q100742
Q100743
Q090740
Q100744
U011945
U011946
U011947
Q100745
Q110762
R081031
Q110763
Q110765
Q110766
Q110769
T061690
Q110771
Q110778
Q120786
S021357
Q120794
Q120795
Q120796
Q120800
R010808
R010810
R020834
R020835
R020836
R040941
R040942
R040943
R040944
T041657
R040945
R040946
R040947
R040948
R040949
R040950
R050951
R050953
T061691
R060974
R060975
R060976
R060977
U021992
R060980
R060982
R060983
R091070
R111187
T091823
R071008
T011616
T011617
R071009
R081028
R081058
R091073
R081059
R091067
T071755
R091068
R091071
R101153
R091069
R091072
T061725
R091075
R091079
S061491
S061499
R101146
R101148
R101147
R101154
R101150
R101151
R111162
S021352
S021381
S021382
R111163
R111170
V092602
V092605
V092606
R111164
R111171
R111173
R111174
R111175
R111165
R121224
R121226
R121227
R121228
S011275
S011277
U092140
U092142
R121229
R121231
R121230
S011264
S011273
S011279
R121233
R121234
R121236
R121239
R121241
V122774
R121243
S011251
S011252
S011253
S011255
S011256
O080406
S011259
S011310
S011314
S011262
S011270
S011272
S011284
S011286
R091074
N050269
N050270
N080287
N090288
S011274
S011278
S011282
S011283
S011285
S061501
S011287
S011289
S011309
V092614
S011290
Q110770
S011298
V052400
V092595
S011311
S011288
S021417
S011312
S011313
S011315
S021353
S021359
S021355
S021356
S021368
S021372
S021373
S021374
S021375
S021392
S021393
S021394
S021397
Q110772
Q110777
R071006
R101149
R121242
S021396
S021399
S021408
S021409
S041421
R030885
R040911
R040912
R040913
R040914
R040915
R040940
S021410
S041430
S041431
S021411
S021412
S021413
S021414
S021415
U021987
S041423
S101554
S111571
V072478
S041424
S051440
M120192
J120040
J080023
L050096
T031655
T041661
T061686
T061687
T061688
T061689
S041425
V102663
S041427
T121940
U082135
S051462
S051465
S051470
S051473
S061487
S061481
S061482
S061485
S041426
S051456
S051464
S051466
S051469
S051472
S051467
S061488
V052408
V012244
V012248
S111591
S121593
P060515
P060516
S011276
S061483
T081808
S061492
S061506
S091532
S061509
T091829
T091830
S081520
S081521
S081523
S081524
R091076U
R091077U
Q110767U
S081531
S091533
S091539
S091551
S101553
S101555
S111569
S111570
S111572
S111573
S111574
T071750
S111575
S111576
S111582
S111592
S121584
S121596
S121585
T011615
T011618
T011619
T011620
S121590
T011621
T011622
T021627
T021628
T021629
T021633
T041658
U021988
T031642
T031643
T031646
T031644
T031645
T031648
2012022854
T031649
T041656
T041659
T041660
V042326
T041668
T041670
T061721
T061722
T061723
T061724
T061726
T061727
T061728
T071746
T071747
T071748
T071749
T071751
T011623
T011624
T011625
T011626
S061489
S061486
2012012806
2012032876
2012032877
T071753
T071754
T081795
T081796, T081797
T081798, T081800
T081799, T081801
T081802, T081803
T081804, T081805"
T081807
T091822
T091825
T091826
T091827
T091831
T091852
T091854
T101888
T111893
T111896
T110920
T111889
T111890
T111891
T111892
T111895
T111894
T111898
T111903
T081791
T081792
T081793
T081794
T111897
T111904
T111905
T111909
T111910
T111911
T111912
T111914
T111916
T111918
T111923
T111924
T111925
T121929
T121930
L050097
L080099
M020134
Q050648
Q050649
J080026
T121932
T121933
T121934
S021403
S021384
S021385
S021386
S021387
S021388
S021389
S021390
S021395
Q120801
T121935
S021376
S021378
S021383
T121938
T121939
U011948
U011949
U011952
U021984
U021985
U021989
U021990
U021991
U021993
U031994
U032001
U032002
U032003
U032004
U032006
U032007
U032008
U032009
U032015
U032017
U032018
U032019
U032020
U032021
U032022
U032024
U032025
U072089
U072090
U072091
U072093
U032023B
U042040, U052056
U112184, V062426
V072490, V022258
Q080723, R081065
U052048
U052049
U052052
U052058
U052059
U052060
U052062
U052068
V092553
U052069
V122724
U052070
U062081
U072094
U072095
V052407
V112701
U072096
U072097
U072106
U072107
U072110
U072111
U072112
U082126
U082127
U082136
V072477
U092144
M020130
M120195
P100553
U092146, N100302
O060374, O070377
P120576, N100302
O060374, O070377
P120576, U032012
U092148
U092150
U102173
U102174
U102175
U102176
U102177
U112190
U112191
U112192
U112194
U092152
U092153
U092156
U082128
S111583
T091828
U102160
P050504
P010457
O090424
U102161
Q070629
U102162
U102163
U102164
U102165
U102166
U102167
U102168
U102169
U102170
U102171
U102172
U102178
U112180
U112181
U122210
U122211
U122212
U122213
U122214
U122215
U122216
U122217
U122218
U122219
V012230
V012231
V012232
V012233
V012234
V012235
V012236
V012237
V012238
V012239
V012241
V012245
T071741
R111183
R121221
S061476
V012250
V012253
T091824
V012254
V022270
V022271
V022272
V022273
V022274
V022275
V022276
V022277
V022278
V022279
V022281
V02225
V022256
V022257
V022259
V022260
V022261"
V022262
"V022280
U092159"
V022282
"V022284
U112188"
"V022285
V022288
V022289"
"V022287
R081029
R121225
R121232
S011258
S011260
S011271"
"V032291
V032292
S121594
T091832"
"V032293
U092149"
V032294
V032296
"V032297
V032298"
"V032299
T071752"
V032303
V032304
V032312
V032313
V042325
"V042328
P120580
P120581"
"V042330
V072464
K020042
U052061
O070395
O070399"
V042331
"V042332
V082492
V082494
V082495
V082496
V082498
V082499"
"V042333
V032290
U052051"
"V042349
V082491"
"V042350
V042351
V042352
V122722
V122735
V032295"
V042355
V042357
V052370
"V052371
R111176
R111186"
V052375
V052376
"V052379
V052380
U092158
U112193"
V052381
"V052385
V052388"
V052390
"V052391
V052392"
V052393
V052399
"V052401
U052050"
"V052402
P080542
P080544
P080545
P100554
Q120787
S061503"
"V052403
V092611"
"V052404
V092598
V092599"
V062427
"V072471
2012032909"
"V072474
V072475
V072476"
V072479
V072486
"V082493
V082497
V082500
V082521
V082522"
"V092554
V092558"
V092555
V092557
V092559
V092560
V092576
V092577
V092578
V092580
V092587
"V092589
V092590
V092591
Q040635
Q110768"
"V092592
V092596
V092597
T031647
V082523
V092551
V092552"
V092593
V092600
V092601
"V092603
V092609
V092610"
V092607
V092608
V092612
V092613
V092615
"V102616
V102617
V102618"
"V102619
S061498
Q060666
Q060678"
"V102620
V122717"
V102621
"V102622
U072088"
"V102634
V102635"
"V102636
V102637
V102638"
V102639
V102640
V102644
"V102651
V102665"
"V102655
R081030"
"V102660
P120579
U052055"
"V112668
V112670
V122716
V112666"
"V112669
2012012807"
V112670
V112671
"V112679
V112680"
V112691
V112693
V112694
"V112695
V112702"
V112704
"V112705
P050497
U102179
V022286"
"V112706
V102625
V102633"
V112707
"V112708
V122746
V122747"
"V122718
V122720"
V122721
"V122725
V122726
V122727"
"V122731
U092157
V072472
V072473"
V122734
"V122748
L100106
P080539"
V122749
V122750
"V122750
V122775"
V122771
V122772
V122773
|
Recalling Firm/
Manufacturer |
Belmont Instrument Corporation
780 Boston Rd
Billerica, Massachusetts 01821-5925 |
| For Additional Information Contact |
Uri Labadini, BS MT (ASCP), BSEE
978-663-0212 Ext. 128
|
Reason for
Recall |
Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.
|
| Action |
Belmont Instrument initiated recall on 9/25/12. A "Field Correction" notice was provided that described the product issue and recommended actions. US-based sales representatives visited all facilities to provide the modified power cord/shield. For units sold outside the United States, the modified power cords were sent to distributors who would ensure the new power cords were provided to all facilities within their accounts. |
| Quantity in Commerce |
2,913 units |
| Distribution |
Worldwide Distribution including Nationwide (USA) and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, England, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Jordan, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Peru, Puerto Rico, S. Korea, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, UK, United Arab Emirates, and Vietnam. |
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