Date Initiated by Firm |
April 28, 2022 |
Create Date |
July 11, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1360-2022 |
Recall Event ID |
90389 |
510(K)Number |
K112427
|
Product Classification |
Tank, holding, dialysis - Product Code FIN
|
Product |
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) |
Code Information |
UDI-DI: 00852456007085
Serial numbers:
SERIAL #
IMP-113766
5202061411P
5201081501
IMP-112232
IMP-120373
IMP-112737
IMP-112606
IMP-113620
IMP-113580
IMP-113085
IMP-112842
IMP-113812
IMP-119050
IMP-113811
IMP-114975
IMP-113810
IMP-115147
IMP-115148
IMP-116155
IMP-116060
IMP-117241
IMP-115146
IMP-115145
IMP-116662
IMP-116996
IMP-117110
IMP-117278
IMP-117739
IMP-117979
IMP-118086
IMP-118103
IMP-118376
IMP-118568
IMP-118704
IMP-118765
IMP-119049
IMP-119343
IMP-118802
IMP-119503
IMP-119757
IMP-119788
IMP-120188
IMP-120172
IMP-120238
IMP-120699
IMP-120187
IMP-114976
IMP-119872
IMP-120959
IMP-120890
IMP-121099
IMP-121101
IMP-121883
IMP-117219
IMP-121980
IMP-122289
IMP-122582
IMP-122943
IMP-115144
IMP-123041
IMP-124680
IMP-825374
IMP-124893
IMP-825418
IMP-124862
IMP-124679
IMP-825865
IMP-826655
IMP-826884
IMP-826438
IMP-826928
IMP-826544
IMP-827363
IMP-827511
IMP-827244
IMP-830445
IMP-826812
IMP-827461
IMP-119513
IMP-827602
IMP-828401
IMP-119388
IMP-121100
IMP-829313
IMP-830965
IMP-831004
IMP-122583
IMP-830617
IMP-831413
IMP-831594
IMP-831197
IMP-831894
IMP-831929
IMP-832283
IMP-832381
IMP-832706
IMP-113809
IMP-832925
IMP-833088
IMP-833120
IMP-833428
IMP-833769
IMP-833916
IMP-833942
IMP-830374
IMP-120755
IMP-834278
IMP-833473
IMP-834575
IMP-834798
IMP-123026
IMP-835190
IMP-835138
IMP-835454
IMP-835973
IMP-838703
IMP-839160
IMP-840230
IMP-840914
IMP-831334
IMP-120670
|
Recalling Firm/ Manufacturer |
Isopure Corp 11851 Plantside Dr Louisville KY 40299-6328
|
For Additional Information Contact |
Isopure Customer/Technical Support 502-267-7873
|
Manufacturer Reason for Recall |
Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.
|
FDA Determined Cause 2 |
Other |
Action |
Firm began to call customers on April 28, 2022, to determine if the IsoMix Pro is still in use at each location. The firm will also be sending an email out to all clinics along with an updated Safety Notice. Once information is gathered, service technicians will visit each clinic to assess the devices.
Customers will be provided with a video link as part of an inspection packet on proper use of a torque screwdriver. Customers should follow the provided guidance documents. Customers should always replace any depleted or blown fuses with the correct size. Customers are also instructed to follow the recommended preventive maintennace schedule for the device. |
Quantity in Commerce |
119 |
Distribution |
Domestic distribution to AL
AZ
CO
DE
FL
GA
IN
KS
KY
LA
MA
MD
ME
MN
MO
NC
NY
OK
PA
TX
UT
VA
WV
No foreign distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = FIN and Original Applicant = ISOPURE CORP.
|