B. Braun Medical Inc. Issues Nationwide Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"

Recall -- Firm Press Release

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. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

B. Braun Medical Inc. Issues Nationwide Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"
Contact:
B. Braun Medical Inc.
(800) 227-2862
FOR IMMEDIATE RELEASE -- September 14, 2007 - B. Braun Medical Inc., Bethlehem, PA, announced on July 30, 2007 a voluntary nationwide recall of Normal Saline Flush syringes with lot numbers ending in "SFR" due to an increase in customer complaints for particulate matter in the saline. The FDA has been apprised of this action.
The introduction of particulate matter into the blood stream may result in phlebitis and / or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause severe injury and / or death. Symptoms would generally be expected to develop quickly and are unlikely to develop more than 24 - 48 hours after the administration of the product. However, the risk associated with use of this product is cumulative and increases with each additional exposure. A patient may not develop any symptoms until they have received multiple doses of the product. To date, B. Braun has received no reports of any patient injury associated with this issue.
Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to usage of this product. Customers that have the affected product in their possession may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
This voluntary recall affects normal saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587. Between June 11 and July 18 of this year, B. Braun Medical Inc. distributed approximately 33,000 units of product code 513584 and 1.2 million units of product code 513587 of lot numbers ending in "SFR" to hospitals and distributors. The product code, identified as REF, and lot number, identified as LOT, can be found on the syringe label just below the product description.
These flush syringes have been found to contain particulate matter, which has been identified as a medical grade silicone. While this silicone is biocompatible, routinely used in the medical device industry and is an expected component of these syringes, the visible particulate matter caused by the silicone in these "SFR" lots may pose a health risk.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
* Fax: 1-800-FDA-0178

Strong America Limited Issues Alert on Undeclared Sulfites in Great Wall Brand Chinese Wolfberry

Strong America Limited Issues Alert on Undeclared Sulfites in Great Wall
Brand Chinese Wolfberry


Contact:
Mr. Yang
(718) 628-6200

FOR IMMEDIATE RELEASE -- Long Island City, NY -- September 10, 2007 --
Strong America Ltd. of Long Island City, NY is recalling Chinese
Wolfberry, because it may contain undeclared sulfites. People who have a
severe sensitivity to sulfites run the risk of serious or
life-threatening reactions if they consume this product.

The recalled Great Wall brand Chinese Wolfberry is packed in uncoded 7oz
packages and were sold in GA, NY, and TN.

No illnesses have been reported to date.

The recall was initiated after routine sampling by the New York State
Department of Agriculture and Markets Food Inspectors and subsequent
analysis by the Department's Food Laboratory personnel revealed the
presence of sulfites in the product, which were not declared on the
label. The consumption of 10 milligrams of sulfites per serving has been
reported to elicit severe reactions in some asthmatics; Anaphylactic
shock could occur in certain sulfites sensitive individuals upon
ingesting 10 milligrams or more of sulfites. Analysis of the Chinese
Wolfberry revealed that it contained 12.87 milligrams per serving.

Consumers who have Great Wall brand Chinese Wolfberry can return the
product to the place of purchase for a full refund. Consumers with
questions may contact the company at 718-628-6200

Abbott Notifies Users of Precision XtraT, OptiumT, ReliOnR Ultima, Rite AidR and KrogerR Blood Glucose Meters to Check Display Screens

Urgent: Abbott Notifies Users of Precision Xtra(tm), Optium(tm),
ReliOn(r) Ultima, Rite Aid(r) and Kroger(r) Blood Glucose Meters to
Check Display Screens


Contact:
Tama Antonia Donaldson
(510) 749-5449

FOR IMMEDIATE RELEASE -- Alameda, CA -- August 31, 2007 -- Abbott is
initiating a worldwide medical device correction for users of its
Precision Xtra(tm), Optium(tm), ReliOn(r) Ultima, Rite Aid(r) and
Kroger(r) blood glucose meters manufactured after January 31, 2007. If
the meter is dropped on a hard surface, part or all of the display
screen may not work properly or may appear blank, which could result in
an inability to view blood glucose test results. The inability to
generate blood glucose results could result in significant risk for
hypoglycemia or hyperglycemia.

Users of these meters who note that the display screen is not working
properly should immediately stop using their meter as referenced in the
User Guide and call Abbott Diabetes Care customer care for assistance at
1-877-844-4404. Through internal testing, Abbott Diabetes Care has found
that when recently produced meters are dropped onto a hard surface, part
of the display can be jarred or disconnected, thereby making it
difficult to read the lot number or date information, or causing the
screen to appear blank. No injuries have been reported to date.

Patients should keep their glucose meters in the wallet provided to
offer additional protection for the meter. If the meter is dropped on a
hard surface, patients should immediately perform a meter display check.
Instructions on how to do this are detailed in the meter's Users Guide.
If no problems are encountered during the automatic display check, the
meter is ready for use. Customers may call Abbott Diabetes Care customer
care at 1-877-844-4404 to determine the date their meter was
manufactured. Customers may also call customer care if they have
questions or need a replacement meter.

Precision Xtra(tm), Optium, ReliOn(r) Ultima, Rite Aid(r) and Kroger(r)
blood glucose meters have been distributed via retail and mail order
pharmacies, physician offices and distributors. Abbott is notifying
physicians, pharmacists, distributors and registered users by letter.

Blood glucose test strips used with these meters are not affected by
this notification.

More information about this notification is available on the company's
website, www.abbottdiabetescare.com
.

Jensen's Old Fashioned Smokehouse Inc. Recalls Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC brand Smoked Salmon Spread

Jensen's Old Fashioned Smokehouse Inc. Recalls Jensen's Seattle Style
Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC brand Smoked
Salmon Spread Because of Possible Health Risk


Contact:
Mike Jensen
206-669-7590

FOR IMMEDIATE RELEASE -- Seattle, WA -- September 7, 2007 -- Jensen's
Old Fashioned Smokehouse Inc. of Seattle, WA is recalling 480 tubs of
Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion
and 132 tubs of PCC brand Smoked Salmon Spread all-natural, because they
have the potential to be contaminated with Listeria monocytogenes, an
organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune
systems. Although healthy individuals may suffer only short-term
symptoms such as high fever, severe headache, stiffness, nausea,
abdominal pain and diarrhea, Listeria infection can cause miscarriages
and stillbirths among pregnant women.

Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC
brand Smoked Salmon Spread all - natural were distributed in retail
stores in Western Washington.

Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion is
coded Sell By 10/14/07 and 10/15/07, and PCC brand Smoked Salmon Spread
all-natural is coded Sell By 9/29/07. Both products were sold in 7 oz.
plastic tubs.

No illnesses have been CONFIRMED to date. The recall was the result of a
routine sampling program by the company which revealed that the finished
products contained the bacteria.

Consumers who have purchased Jensen's Seattle Style Wild Smoked Salmon
Spread Lemon Dill and Onion, and PCC brand Smoked Salmon Spread all -
natural are urged to return it to the place of purchase for a full
refund. Consumers with questions may contact the Quality Assurance
Department at Jensen's Smokehouse at 206-364-5569.

Listeria Detected in Organic Pastures Raw Cream

Listeria Detected in Organic Pastures Raw Cream
CDFA Issues Order to Withdraw Product; No Illnesses Reported


Contact:
Steve Lyle
916-654-0462

FOR IMMEDIATE RELEASE -- Sacramento, CA -- September 7, 2007 -- The
California Department of Food and Agriculture has issued an order to
Organic Pastures Dairy Company to withdraw from retail distribution
Grade A raw cream manufactured at their facility in Fresno, due to
detection of Listeria monocytogenes bacteria.

Under the recall, Organic Pastures brand Grade A raw cream with code
dates SEP 14 through SEP 21 is to be pulled immediately from retail
shelves and consumers are strongly urged to dispose of any product
remaining in their refrigerators. Until further notice, Organic Pastures
may not produce raw cream for the retail market.

The quarantine order came following laboratory confirmation of Listeria
monocytogenes bacteria. CDFA inspectors found the bacteria as a result
of product testing conducted as part of routine inspection and sample
collection at the facility.

The withdrawal order involves removal of raw cream from grocery stores,
retail outlets and farmers markets throughout California.

The great majority of cream consumed in California is pasteurized. Raw
cream is not. Pasteurization eliminates the risk of bacterial illness.

Listeria monocytogenes may cause listeriosis among "at risk" people,
including pregnant women, newborns, older adults, and people with
weakened immune systems. Symptoms include fever, muscle aches, and
sometimes nausea or diarrhea. If infection spreads to the nervous
system, symptoms such as headache and stiff neck can occur. Infected
pregnant women may experience only a mild, flu-like illness; however,
infections during pregnancy can lead to more serious problems for the
fetus. Consumers should seek immediate medical care if they develop
these symptoms.

Consumers should discard the raw cream or return it to the place of
purchase for a refund. California consumers who have purchased Organic
Pastures brand raw cream may call the company at 559- 352-6585 with
questions about the product withdrawal.

Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore Tabs, a Product Marketed as a Dietary Supplement

Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore
Tabs, a Product Marketed as a Dietary Supplement


Contact:
Bodee LLC
help@zencoretabs.com

FOR IMMEDIATE RELEASE -- Century City, CA - August 31- Bodee LLC, 2222
Avenue of the Stars, 702E, Century City, CA 90067, announced today that
it is conducting a voluntary nationwide recall of all the company's
supplement product sold under the name Zencore Tabs.

Bodee LLC is conducting this recall after being informed by
representatives of the Food and Drug Administration (FDA) that lab
analysis by FDA of Zencore Tabs samples found the product contains
potentially harmful, undeclared ingredients. FDA asserts that its
chemical analysis revealed that one lot of Zencore Tabs contains
aminotadalafil, an analog of tadalafil, the active ingredient of a
FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains
Aminotadalafil is close in structure to tadalafil and is expected to
possess a similar pharmacological and adverse event profile. Further,
FDA declares another lot of Zencore Tabs contains sildenafil, the active
ingredient of another FDA-approved drug used for ED, as well as
sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil.
All of these undeclared chemicals pose a threat to consumers because
they may interact with nitrates found in some prescription drugs (such
as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart
disease often take nitrates. ED is a common problem in men with these
conditions, and consumers may seek these types of products to enhance
sexual performance.

Zencore Tabs is sold in health food stores and by mail order nationwide
and in Canada. The Zencore Tabs product is sold as a 2-capsule blister
pack packaged in a retail booklet with five booklets in a box.

Customers who have this product in their possession should stop using it
immediately and contact their physician if they have experienced any
problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should
be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or
by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers
Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for
a full purchase price refund by calling (800) 935-0296 for instructions
on the return and refund process.

The Company is taking this voluntary action because it is committed and
is always concerned with the health of persons who have consumed this
product. The Company is reviewing the procedures and policies of all
firms involved with the manufacture of the product to ensure that there
will be no future issues with regard to Zencore Tabs' composition. The
Company is working closely with the FDA in the recall process and is
committed to the quality and integrity of its products. It sincerely
regrets any inconvenience to consumers and its other customers.

Consumer Advisory: State Agriculture Director Issues Food Safety Alert for Potato Salad

Consumer Advisory: State Agriculture Director Issues Food Safety Alert
for Potato Salad


Contact:
Communications Office
614-752-9817

FOR IMMEDIATE RELEASE -- August 31, 2007 -- Ohio Department of
Agriculture (ODA) Director Robert Boggs in conjunction with The Kroger
Co. today advises consumers not to consume Kroger brand Mustard or
Southern-Style potato salad with a "Best If Used By" date of Sept. 5,
2007, because it may contain E. coli O157:H7.

ODA's Consumer Analytical Laboratory tested a sample of the Kroger brand
Mustard or Southern-style potato salad collected during routine food
safety sampling, and found it positive for E. coli O157:H7, a foodborne
pathogen.

To date, no illnesses have been reported, and additional samples
analyzed by a certified, thirdparty laboratory contracted by Kroger have
tested negative for E. coli O157:H7. As a precautionary measure, The
Kroger Co. has removed the product from sale. The company encourages
consumers to check their refrigerators and freezers for this specific
product and, if found, to return it to the store for a full refund.

For more information regarding this product withdrawal, please visit
www.kroger.com .

Through ODA's Division of Food Safety, the department helps assure
consumers are provided foods, over-the-counter drugs, dietary
supplements, and cosmetics that are safe, unadulterated, and honestly
presented. Random, routine testing at the department's Consumer
Analytical Laboratory helps identify potentially dangerous or
adulterated products. In addition to advising consumers, the department
has notified the Food and Drug Administration and local health
departments.