| KCER:
KIDNEY COMMUNITY EMERGENCY RESPONSE COALITION
Alerts
& Recall Notifications
The
kidney community uses a variety of products and resources to ensure
the health and safety of patients and healthcare professionals.
The United States Food and Drug Administration (FDA) issues alerts
and notifications when these products and resources are unsafe
or being recalled.
As
directed by CMS, the KCER Coalition issues notices on FDA recalls
via email and this website for the kidney community. To join the
email list, please email sburris@nw7.esrd.net.
January
28, 2010
RECALL:
Edwards Lifesciences Aquarius Hemodialysis System
FDA
and Edwards Lifesciences notified healthcare professionals of
a Class I recall of the Aquarius Hemodialysis System due to reports
of clinically significant fluid imbalance and the potential for
users to repeatedly override the fluid imbalance alarm. This could
result in a decrease or increase in the volume of the circulating
blood, which may result in serious injuries or death. The recall
includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700,
and GEF09800, using Software version 6.00.04. The product was
distributed from July 12, 2007 through March 18, 2009. Baxter
International, Inc. is the U.S. distributor of the Aquarius. The
company notified its customers of a planned software upgrade to
prevent users from bypassing the fluid balance alarm more than
five times in a 20-minute period. The company received reports
of clinically significant fluid imbalance. When a certain level
of fluid imbalance is detected the Aquarius will trigger an alarm.
However, users are able to override this alarm and continue therapy.
By repeatedly overriding the balance alarm without solving the
issue, such as a closed clamp or kinked line, it is possible to
remove too much fluid from or replace too much fluid to the patient.
In extreme cases, this could result in a decrease or increase
in the volume of the circulating blood, which may result in serious
injuries or death. Public Contact: Baxter International,
Inc. is the U.S. distributor of the Aquarius. For questions regarding
the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.
Click
here for more information.
January
21, 2010
Nipro
Medical Corporation Issues a Voluntary Recall of All GlucoPro
Insulin Syringes
Nipro
Medical Corporation, Miami FL, is initiating a nationwide recall
of all GlucoPro Insulin Syringes (This does not include
the GlucoPro syringe specific for use with the Amigo Insulin pump).
These syringes may have needles that detach from the syringe.
If the needle becomes detached from the syringe during use, it
can become stuck in the insulin vial, push back into the syringe,
or remain in the skin after injection. Consumers who have GlucoPro
Insulin Syringes should stop using and return them to point of
sale for reimbursement. This recall includes all product codes
and lot numbers with expiration dates before 2011-11 (Nov 1, 2011).
The firm voluntarily recalled the products after learning of the
possibility of needle detachment. FDA has been apprised of this
action. No injuries have been reported to date. Product was distributed
nationwide, including Puerto Rico. Company is notifying its distributors
and customers by Fax and Email and is arranging for return of
all recalled products. Consumers with questions may contact the
company at 305.599.7174 x249. Click
here for more information.
October
27, 2009
Accusure
Insulin Syringes Qualitest Pharmaceuticals - Recall
Qualitest
Pharmaceuticals and FDA notified healthcare professionals of a
nationwide recall of Accusure Insulin Syringes. All syringes,
regardless of lot number, are subject to this recall. These syringes
were distributed between January 2002 and October 2009 to wholesale
and retail pharmacies nationwide (including Puerto Rico). The
syringes in these lots may have needles which detach from the
syringe. If the needle becomes detached from the
syringe during use, it can become stuck in the insulin vial, push
back into to the syringe, or remain in the skin after injection.
Consumers who have any Accusure® Insulin Syringes should stop
using them and contact Qualitest at 1-800-444-4011 for reimbursement.
You can find the lot number on the white paper backing of each
individual syringe. Click
here for more information.
October
19, 2009
Dexferrum
(iron dextran injection) - Labeling Change
American
Regent and FDA notified healthcare professionals that anaphylactic-type
reactions, including fatalities, have followed the parenteral
administration of iron dextran injection. The Boxed Warning has
been modified to recommend administering a test dose prior to
the first therapeutic dose and observing for signs or symptoms
of anaphylactic-type reactions
during administration of Dexferrum. Fatal reactions have followed
the test dose of iron dextran injection, even in situations where
the test dose was tolerated. Patients with a history of drug allergy
or multiple drug allergies may be at increased risk of anaphylactic-type
reactions. It is recommended that resuscitation equipment and
personnel trained in the detection and treatment of anaphylactic-type
reactions be readily available during Dexferrum administration.
For more information, visit FDA
Medwatch and American
Regent.
October
12, 2009
Unomedical
Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
Unomedical
Inc., a manufacturer of medical devices, today announced that
it is conducting a voluntary recall of certain units of the single-patient
use Manual Pulmonary Resuscitator (MPR). The
recall only impacts MPRs manufactured from July 2002 – March
2008 and matching the lot numbers listed on the following Unomedical
web page: http://www.unomedical.com/?pageid=H3160.
Unomedical is contacting customers to arrange for the return and
credit of all MPR units subject to this recall by sending notification
letters to distributors and customers. Customers with questions
are urged to contact Unomedical at 1-800-634-6003.
October
3, 2009
Philips
Issues Worldwide Recall of Select Heartstart Fr2+ Automated External
Defibrillators
Philips
announced today that it is voluntarily recalling approximately
5,400 HeartStart FR2+ automated external defibrillators (AEDs).
This recall is being conducted due to the possibility of a memory
chip failure that may render the device inoperable. Only certain
HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by
Philips; and models M3840A and M3841A, distributed by Laerdal
Medical) manufactured between May, 2007 and January, 2008 are
included in the voluntary recall. For more information, visit
http://www.fda.gov/Safety/Recalls/ucm185108.htm
October
1, 2009
New
USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect
in some patients *NEW*
The
U.S. Food and Drug Administration today alerted health care professionals
to a change in heparin manufacturing that is expected to decrease
the potency of the common blood-clotting drug.
To ensure the quality of heparin and to guard against potential
contamination, the United States Pharmacopeia (USP), a nonprofit
standards-setting organization, adopted new manufacturing controls
for heparin. These changes include a modification of the reference
standard for the drug’s unit dose.
Manufacturers in the United States label the amount of heparin
included in their products based on USP standards. The changes
adopted by the USP for the heparin unit dose match the World Health
Organization’s International Standard (IS) unit dose definition
that has been in use in Europe for many years. The revised USP
reference standard and unit definition for heparin is about 10
percent less potent than the former USP unit.
September
16, 2009
LIFEPAK
CR Plus Automated External Defibrillators (Physio-Control, Inc)
Audience:
Emergency medical
personnel, consumers. FDA notified healthcare professionals of
a Class I recall of certain LIFEPAK CR Plus Automated External
Defibrillators (AED) manufactured and distributed from July 9,
2008 through August 19, 2008. An extremely humid environment may
cause the affected devices to improperly analyze the heart rhythm
and may cause the device to delay or fail to deliver therapy.
Click
here to find the serial numbers associated with this recall.
An extremely humid environment may cause the LIFEPAK CR Plus AED
to improperly analyze the rhythm correctly and may cause the device
to delay or fail to delivery therapy. Class I recalls are the
most serious type of recall and involve situations in which there
is a reasonable probability that use of these products will cause
serious injury or death. Click
here for more information about this recall.
September
3, 2009
Myfortic
(mycophenolic acid)
Audience: Renal, cardiac, and hepatic transplantation healthcare
professionals.
Novartis and FDA notified healthcare professionals that
cases of Pure Red Cell Aplasia (PRCA) have been reported in patients
treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections
of the Myfortic Prescribing Information have been revised to reflect
this new safety information. PRCA is a type of anemia in which
there is a selective reduction of red blood cell precursors on
bone marrow examination. Patients with PRCA may present with fatigue,
lethargy, and/or abnormal paleness of the skin (pallor). In some
cases, PRCA was found to be reversible with dose reduction or
cessation of Myfortic therapy. In transplant patients, however,
reduced immunosuppression may place the graft at risk. Read
the complete MedWatch Safety summmary (corrected) by clicking
here.
August
26, 2009
Levemir
Insulin (Novo Nordisk):Stolen vials still may be on market
FDA
is reminding the public that stolen vials of the long-acting insulin
Levemir made by Novo Nordisk Inc. still may be on the market.
Evidence gathered to date suggests that the stolen insulin was
not stored and handled properly and may be dangerous for people
to use. FDA has received multiple reports of patients who suffered
an adverse event due to poor control of glucose levels after using
a vial from one of the stolen lots. Read the complete MedWatch
2009 Safety summary including a link to the FDA News release and
the original June 13,2009 alerts here.
August
24, 2009
Accusure
Insulin Syringes [31G, 1/2 cc and 1 cc]
Audience: Patients with diabetes mellitus, pharmacists and
diabetes healthcare professionals. Qualitest Pharmaceuticals
and FDA notified patients and healthcare professionals of a voluntary
nationwide recall of two lots of Accusure Insulin Syringes. The
syringes in these lots have been found to have needles which can
detach from the syringe. When the needle becomes detached from
the syringe during use, it can become stuck in the insulin vial,
push back into the syringe, or remain in the skin after an injection.
Consumers who have any recalled Accusure Insulin Syringes (31
G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1
or lot number 7CPT1) should stop using them and contact Qualitest
at 1-800-444-4011 for product replacement instructions. The lot
number can be found on the white paper backing of each individual
syringe. These recalled products were distributed from January
2007 through June 2008 to wholesalers and retail pharmacies nationwide
(including Puerto Rico). This
information is posted here.
August
13, 2009
GDH-PQQ
(glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring
Technology
Audience: Diabetes healthcare professionals, hospital risk managers,
patients. FDA notified healthcare professionals of the possibility
of falsely elevated blood glucose results when using GDH-PQQ glucose
test strips on patients who are receiving therapeutic products
containing certain non-glucose sugars. These sugars can falsely
elevate glucose results, which may mask significant hypoglycemia
or prompt excessive insulin administration, leading to serious
injury or death.
GDH-PQQ
glucose monitoring measures a patient’s blood glucose value
using methodology that cannot distinguish between glucose and
other sugars. Certain non-glucose sugars, including maltose, xylose,
and galactose, are found in certain drug and biologic formulations,
or can result from the metabolism of a drug or therapeutic product.
The FDA Public Health Notification provides a list of GDH-PQQ
Glucose Test Strips and recommends that healthcare practitioners
avoid using GDH-PQQ glucose test strips in healthcare facilities
or take steps to never use them on patients receiving interfering
substances.
May
6, 2009
CDC:
Hepatitis B Vaccine
In
December 2008, Merck communicated with CDC that it expected to
deplete available adult and dialysis formulations
of their hepatitis B vaccine, Recombivax HB® in the first
quarter of 2009. Once depleted, these formulations will be unavailable
for the remainder of 2009. Supply of GSK's Adult hepatitis B vaccine
(Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination
vaccine (Twinrix®) is sufficient to meet demand for routine
adult usage of this vaccine as well as CDC's ongoing High Risk
Adult Hepatitis B Initiative. This information is posted at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm
May
6, 2009
Disetronic
Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump
Audience:
Diabetes healthcare professionals, patients. Disetronic Medical
Systems Inc. and FDA notified healthcare professionals about a
defect in the “up” and/or “down” buttons
of some ACCU-CHEK Spirit insulin pumps. This failure may present
as an intermittent or complete loss of function of the “up”
and/or “down” buttons. If the buttons do not function,
users may not be able to change any programmed setting on the
pump. If this failure occurs, the pump may not respond with a
vibration or acoustic confirmation signal to a button press and
the display will remain unchanged. Users may contact ACCU-CHEK
Spirit hotline noted in the Press Release for a replacement pump
or for any other questions regarding this potential defect.
Read
the complete MedWatch 2009 Safety summary, including a link to
the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit
April
9, 2009
ZOLL
AED Plus Defibrillator
ZOLL
Medical Corporation and FDA notified healthcare professionals
of a Class 1 recall of ZOLL AED Plus Defibrillators distributed
from May, 2004 through February 9, 2009. The recall was initiated
because the device may fail to deliver a defibrillation shock,
which could result in failure to resuscitate a patient during
treatment of sudden cardiac arrest. On February 12 and March 31,
2009, the company sent their distributors and customers recall
letters with recommendations and instructions for customers on
specific steps to mitigate the identified problems with this device.
Please visit http://www.fda.gov/cdrh/recalls/recall-021209b.html
and http://www.zollaedplusbatteryhelp.com/
April
1, 2009
Digoxin,
USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
Caraco
Pharmaceutical Laboratories and FDA notified healthcare professionals
of a consumer-level recall of Caraco brand Digoxin, USP, 0.125
mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31,
2009, which are not expired and are within the expiration date
of September, 2011. The tablets are being recalled because they
may differ in size and therefore could have more or less of the
active ingredient, digoxin, a drug product used to treat heart
failure and abnormal heart rhythms. The drug has a narrow therapeutic
index and the existence of higher than labeled dose may pose a
risk of digoxin toxicity in patients with renal failure. Digoxin
toxicity can cause nausea, vomiting, dizziness, low blood pressure,
cardiac instability, and bradycardia. Death can also result from
excessive digoxin intake. A lower than labeled dose may pose a
risk of lack of efficacy potentially resulting in cardiac instability.
Consumers with the recalled product should return these products
to their pharmacy or place of purchase. Please visit http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html
March
11, 2009
Baxter
recalls Colleague Single and Triple Channel Volumetric Infusion
Pumps
FDA
notified healthcare professionals of a Class 1 Recall of model
numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE
2M9161and 2M9163. These products were manufactured and distributed
from February, 1997 through December, 2008. The company identified
software and battery usage failures that result in a delay in
or interruption of infusion that may cause serious injury and/or
death. Baxter sent a letter to all of its customers, which included
advice and instructions to institutions using the infusion pumps.
Read
the FDA notice at http://www.fda.gov/cdrh/recalls/recall-012309.html
and also read Baxter's press release here.
February
12, 2009
CellCept
(mycophenolate mofetil)
FDA
and Roche Laboratories notified healthcare professionals of the
introduction of a CellCept Medication Guide to provide important
safety information in language that patients can easily comprehend.
FDA regulations require a pharmacist to distribute a copy of the
Medication Guide to every patient who fills a CellCept prescription
from this point forward. FDA has also required the introduction
of a Medication Guide for mycophenolic acid, marketed as Myfortic
by Novartis.
Read
the complete MedWatch 2009 Safety summary including links to the
Dear Healthcare Professional and Dear Pharmacist letters, the
new Medication Guide and the current Prescribing Information,
at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept
December
2, 2008
Innohep
(tinzaparin sodium injection)
FDA
has received information about the clinical study: Innohep in
Renal Insufficiency Study (IRIS) that was stopped in February,
2008 by the study’s Data Safety Monitoring Committee because
of an interim finding of an increase in all-cause mortality in
patients who received Innohep. Information on the patients enrolled
in the study, on the heparin used to manufacture Innohep, and
on the heparin used in the study is still being collected and
analyzed.
In
July 2008, the company revised the prescribing information to
restrict the use of Innohep in patients 90 years of age or older.
FDA is concerned that the preliminary data from the IRIS study
suggest that the increased risk of mortality is not limited only
to patients 90 years of age or older. Therefore, FDA has requested
that the company revise the labeling for Innohep to better describe
the overall study results which suggest that, when compared to
unfractionated heparin, Innohep increases the risk of death for
elderly patients (i.e., 70 years of age and older) with renal
insufficiency. Healthcare professionals should consider the use
of alternative treatments to Innohep when treating elderly patients
over 70 years of age with renal insufficiency and DVT, PE, or
both. This communication is in keeping with FDA’s commitment
to inform the public about its ongoing safety reviews of drugs.
FDA anticipates submission of the final IRIS study report in January,
2009 and plans to complete its review soon thereafter. FDA will
communicate its conclusions and any resulting recommendations
to the public at that time. FDA will consider additional regulatory
actions as appropriate after thorough review of all applicable
data from the manufacturer of Innohep.
Read
the complete MedWatch 2008 Safety summary, including a link to
the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
November
6, 2008
ReliOn Insulin Syringes for use
with U-100 Insulin (Tyco Healthcare - Covidien)
Covidien
and FDA notified patients and healthcare professionals of a recall
of ReliOn sterile, single-use, disposable, hypodermic syringes
with permanently affixed hypodermic needles. The mislabeled syringe
may result in patients receiving an overdose of as much as 2.5
times the intended dose, with serious health consequences, low
blood sugar, and even death. These syringes are sold only by Wal-Mart
or Sam's Club pharmacies under the ReliOn name. The recall applies
only to lot number 813900. The product was distributed from Aug.
1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes
in 4,710 boxes. FDA urges patients and health care professionals
to check syringe packaging carefully for products with this lot
number, not to use the product, and return the product to the
pharmacy for replacement. The lot number can be found on the back
panel of the 100 count syringe carton, or on the white paper backing
of each individual syringe “peel-pack”.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html
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