FDA Safety Alert
KCER Release Date: July 3, 2014
Audience: ESRD Networks and Facilities
Also available at: http://kcercoalition.com/resources/alerts-and-recall-notifications/
Recall
FDA posts press releases and other notices of recalls and market withdrawals from the firms
involved as a service to consumers, the media, and other interested parties. FDA does not
endorse either the product or the company.
Class II Recalls of NxStage SAK Dialysate Concentrate
Recalls have been initiated for NxStage SAK Dialysate Concentrate containing aluminum levels
which exceed internal product specification. Please review chart below for lot-specific
information.
Product
Product Description
Type
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-301 Lactate 45,
Potassium 1, Sodium
140, Calcium 3,
Magnesium 1, Chloride
100, Glucose (mg/dL)
100 Batch Size (liters)
60 The SAK is one of the
disposables used with
NxStages PureFlow SL
Dialysate Preparation
System. The SAK is a
disposable bag pre-filled
with dialysate
concentrate that is then
filled with purified
water prepared by
NxStages PureFlow SL
Code Info Classification
Lot codes:
40279015
40179163
40179162
31279127
3067903
3057931
3057930
3047933
3047928
Class II
1
Reason for Recalling
Recall
Firm
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Code Info Classification
Reason for Recalling
Recall
Firm
Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
System One. SAKs are
packaged in a case
containing two SAKs.
SAK product SKUs vary
in the dialysate
concentrate and volume
of the final dialysate
batch.
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-302 Lactate , 40,
Potassium 1, Sodium
140, Calcium 3,
Magnesium 1, Chloride
105, Glucose (mg/dL)
100, Batch Size (liters):
60 The SAK is one of the
disposables used with
NxStages PureFlow SL
Dialysate Preparation
System. The SAK is a
disposable bag pre-filled
with dialysate
concentrate that is then
filled with purified
water prepared by
NxStages PureFlow SL
Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
Lot codes:
40179127
40179107
40179109
40179105
40179093
40179034
31279120
31279118
3057921
3057920
3057915
3057914
3057906
3057905
3047924
3047923
Class II
2
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Code Info Classification
Reason for Recalling
Recall
Firm
System One. SAKs are
packaged in a case
containing two SAKs.
SAK product SKUs vary
in the dialysate
concentrate and volume
of the final dialysate
batch.
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-303 Lactate 45,
Potassium 1, Sodium
140, Calcium 3,
Magnesium 100m
Chloride 100m, Glucose
(mg/dL) 100 Batch Size
(liters) 50 The SAK is
one of the disposables
used with NxStages
PureFlow SL Dialysate
Preparation System.
The SAK is a disposable
bag pre-filled with
dialysate concentrate
that is then filled with
purified water prepared
by NxStages PureFlow
SL Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
System One. SAKs are
packaged in a case
containing two SAKs.
SAK product SKUs vary
Lot codes:
40179030
3067904
3067902
3057925
3057924
3047934
3047929
Class II
3
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Code Info Classification
Reason for Recalling
Recall
Firm
in the dialysate
concentrate and volume
of the final dialysate
batch.
Devices
NxStage Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-304 Lactate 45,
Potassium 2, Sodium
140, Calcium
3,Magnesium 1,
Chloride 101, Glucose
(mg/dL) 100 Batch Size
(liters) 60 The SAK is
one of the disposables
used with NxStages
PureFlow SL Dialysate
Preparation System.
The SAK is a disposable
bag pre-filled with
dialysate concentrate
that is then filled with
purified water prepared
by NxStages PureFlow
SL Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
System One. SAKs are
packaged in a case
containing two SAKs.
SAK product SKUs vary
in the dialysate
concentrate and volume
of the final dialysate
batch.
Lot code:
40179091
40179069
40179068
40179029
40179019
31279094
3067901
3057932
3057919
3057918
3057909
3057908
Class II
4
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-305 Lactate 45,
Potassium 1, Sodium
140, Calcium 3,
Magnesium 1 Chloride
100, Glucose (mg/dL)
100 Batch Size (liters)
40
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-306 Lactate 45,
Potassium 2, Sodium
140, Calcium 3,
Magnesium 1, Chloride
101, Glucose (mg/dL)
100 Batch Size (liters)
50 The SAK is one of the
disposables used with
NxStages PureFlow SL
Dialysate Preparation
System. The SAK is a
disposable bag pre-filled
with dialysate
concentrate that is then
filled with purified
water prepared by
NxStages PureFlow SL
Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
System One. SAKs are
Code Info Classification
Lot codes:
40179026
3057901
3047930
Lot codes:
31279092
3047917
3047916
5
Reason for Recalling
Recall
Firm
Class II
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
Class II
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Code Info Classification
Reason for Recalling
Recall
Firm
packaged in a case
containing two SAKs.
SAK product SKUs vary
in the dialysate
concentrate and volume
of the final dialysate
batch.
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-307 Lactate 40,
Potassium 1, Sodium
140, Calcium 3,
Magnesium 1, Chloride
105, Glucose (mg/dL)
100 Batch Size (liters)
50 The SAK is one of the
disposables used with
NxStages PureFlow SL
Dialysate Preparation
System. The SAK is a
disposable bag pre-filled
with dialysate
concentrate that is then
filled with purified
water prepared by
NxStages PureFlow SL
Dialysate Preparation
System to prepare a
batch of dialysate for
use with the NxStage
System One. SAKs are
packaged in a case
containing two SAKs.
SAK product SKUs vary
in the dialysate
Lot code:
40179126
40179125
40179108
40179036
40179035
31279119
3057923
3057907
3047927
Class II
6
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
FDA Safety Alert
Product
Product Description
Type
Code Info Classification
Reason for Recalling
Recall
Firm
concentrate and volume
of the final dialysate
batch.
Devices
NxStage® Dialysate Sack
(SAK) with Concentrate
for Use with
PureFlowTM SL REF:
SAK-407 Lactate 40,
Lot code:
Potassium 1, Sodium
40179074
140, Calcium 3,
Magnesium 1, Chloride
105, Glucose (mg/dL)
100 Batch Size (liters)
50
Class II
SAK Dialysate
Concentrate
contain
NxStage
aluminum
Medical,
levels which
Inc.
exceed internal
product
specification
###
Content from: http://www.fda.gov/Safety/Recalls/ucm400559.htm
Eight NxStage Product Recall Notices in FDA Enforcement Report for July 2, 2014
#1, #2, #3, #4, #5, #6, #7 and #8.
### end of report###
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