Month: October 2015

For Immediate Release

October 29, 2015

Contact

Consumer

 800-586-1915

Media

 800-586-1915

 

Firm Press Release

National Video Supply located in Santa Clarita, California is voluntarily recalling the following product to the consumer level: RHINO 7 3000 Platinum Capsules packaged in single 1 count blister hang tab cards with UPC # 700729253748 ALL LOT NUMBERS WITHIN EXPIRY. Lot numbers are located on the back top right of the (1) count and on the side of the 6 count bottles. FDA analysis found these products to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA).

Desmethyl carbondenafil may pose a threat to consumers because this PDE-5 inhibitor may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels that can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Dapoxetine has not been approved by the FDA and therefore its safety or efficacy has not been established. Chemically, dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression. Studies have shown that antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening.

National Video Supply has not received a report of any adverse events associated with these products. (more…)

For Immediate Release

October 29, 2015

Contact

Consumers

Hormel Foods Customer Relations
1-866-475-4779

Firm Press Release

Hormel Foods Sales LLC is voluntarily recalling 153 cases, or 1,871 total pounds, of a single code date of SKIPPY® Reduced Fat Creamy Peanut Butter Spread, due to the possibility that some jars may contain small pieces of metal shavings which were discovered on an in-line magnet check during routine cleaning. Foodborne objects that are greater than 7mm in length may cause injury such as severe choking with airway obstruction, gastrointestinal peroration or secondary infection. The recalled product is limited to 16.3 ounce jars with a “Best If Used By” date of DEC1416LR1 with a package UPC code of 37600-10500. The code date is located on top of the lid. A photo of the product and “Best If Used By” date appears below. Recalled product was sent to distribution centers for Publix, Target and Walmart located in Georgia, Virginia, Alabama, North Carolina, South Carolina, Delaware and Arkansas.

The company is issuing the recall to ensure that consumers are made aware of the potential hazard. No reports have been received to date of any consumer injuries or complaints. (more…)

For Immediate Release

October 28, 2015

Contact

Consumers

custserv@questmedical.com
 1-800-627-0226

Firm Press Release

One Allentown Parkway Allen, TX 75002 USA
800-627-0226/www.questmedical.com

On October 28, 2015, Quest Medical, Inc. initiated a nationwide recall of Myocardial Protection System (MPS) Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.

There are no other recalls related to this product.

Consumers who have the applicable lots of the MPS Delivery Set(s) should cease use of the affected lots and contact Quest Medical, Inc. to return the product and request replacement. Additionally, consignees are being notified via written correspondence.

Recalled Product(s) were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.

The following models/UDI/ID numbers are subject to the recall:

MPS® Delivery Sets – Recall
Device Name MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing MPS Delivery Set with 6 ft. delivery tubing MPS Low Volume Delivery Set
Device Model 5001102 5001102-AS 7001102
UDI 00634624501126 00634624521124 00634624701120
Affected Lots 0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04 0493675U04, 0493685U07, 0494465U07, 0494475U09, 0494855G01, 0495215U11 0495225U11, 0495505G02, 0495515G02, 0496535G08, 0496875G08, 0496885G08 0497245S02 0492205E03 0493695U04 0494485U07 0495525G02 0497265S02 0492765E07

The affected product lot information can be identified by product labeling on shipper and individual sterile trays.

Quest Medical, Inc. voluntarily recalled the applicable lots of MPS Delivery Sets after becoming aware of complaints alleging patient blood loss from the device during use. Quest Medical, Inc. has notified the FDA of this action.

The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery. The firm has received twenty (20) complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. There have been no reports of patient injuries as a result of the alleged issue to date. The firm has reported these events via the FDA MEDWATCH program. (more…)

For Immediate Release

October 28, 2015

Contact

Consumers

Sockeye Suzy’s Fish Co.
  suzylumley@yahoo.com
 509-731-0688

Firm Press Release

Sockeye Suzy’s Fish Co. of White Swan, Washington is voluntarily recalling ALL canned catfish, salmon, sturgeon, and walleye with any codes starting with “OC”, sold under brand Sockeye Suzy Fish, because it has the potential to be contaminated with Clostridium botulinum, a bacterium that can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

All products were sold to consumers from our store and distributed to retail stores and wineries in Washington. The last date of distribution of recalled products was September 2015.

The affected OC code can be found on either the bottom or on top of the can. Recalled products are packaged in metal cans with net weight of 6 oz.

Product Name Brand Net Wt. UPC
Fancy Chinook Sockeye Suzy Fish 6 oz. 7 48252 67292 6
Fancy Spring Chinook Sockeye Suzy Fish 6 oz. 7 48252 67412 8
Peppered & Smoked Chinook Sockeye Suzy Fish 6 oz. 7 48252 67282 7
Peppered & Smoked Chinook Sockeye Suzy Fish 6 oz. 7 48252 67302 2
Peppered & Smoked Coho Sockeye Suzy Fish 6 oz. 7 48252 67212 4
Peppered & Smoked Steelhead Sockeye Suzy Fish 6 oz. 7 48252 67332 9
Peppered & Smoked Sockeye Sockeye Suzy Fish 6 oz. 7 48252 67232 2
Smoked Catfish Sockeye Suzy Fish 6 oz. 7 48252 67252 0
Smoked Chinook Sockeye Suzy Fish 6 oz. 7 48252 67282 7
Smoked Chinook Sockeye Suzy Fish 6 oz. 7 48252 67212 4
Smoked Chinook Sockeye Suzy Fish 6 oz. 7 48252 67302 2
Smoked Coho Sockeye Suzy Fish 6 oz. 7 48252 67222 3
Smoked Garlic Chinook Sockeye Suzy Fish 6 oz. 7 48252 67322 0
Smoked Garlic Steelhead Sockeye Suzy Fish 6 oz. 7 48252 67362 6
Smoked Jalapeno Chinook Sockeye Suzy Fish 6 oz. 7 48252 67312 1
Smoked Jalapeno Spring Chinook Sockeye Suzy Fish 6 oz. 7 48252 67392 3
Smoked Jalapeno Sturgeon Sockeye Suzy Fish 6 oz. 7 48252 67272 8
Smoked Jalapeno Steelhead Sockeye Suzy Fish 6 oz. 7 48252 67352 7
Smoked Sockeye Sockeye Suzy Fish 6 oz. 7 48252 67242 1
Smoked Spring Chinook Sockeye Suzy Fish 6 oz. 7 48252 67402 9
Smoked Spring Chinook Sockeye Suzy Fish 6 oz. 7 48252 67382 4
Smoked Spring Chinook Sockeye Suzy Fish 6 oz. 7 48252 67372 5
Smoked Steelhead Sockeye Suzy Fish 6 oz. 7 48252 67342 8
Smoked Sturgeon Sockeye Suzy Fish 6 oz. 7 48252 67262 9
Smoked Walleye Sockeye Suzy Fish 6 oz. 7 94504 39610 2

There have been no reported cases of illnesses associated with our products to date. (more…)

For Immediate Release

October 28, 2015

Contact

Consumers

Sanofi US.
 1-800-981-2491

Media

Karen Sutherland
  USMediaRelations@Sanofi.com
 1-908-989-0726

Firm Press Release

Bridgewater, N.J. – Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.

If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases. (more…)

Recall Summary

Name of product: Girl’s Hoodies

Hazard:

The hoodies have a drawstring inside the lining of the hood that surrounds the face which poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children. In February 1996, CPSC issued guidelines about drawstrings in children’s upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC’s actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts.

Consumer Contact: Maeli Rose at 626-701-7575 from 10:00 a.m. to 4:00 p.m. PT Monday through Friday or online at www.maelirose.com and click on the Recall tab located at the top of the homepage for more information.

Report an Incident Involving this Product

Recall Details

Units

About 1,200

Description

This recall involves the girls’ blush hoodie sizes 2T-6X, made of 62% polyester, 35% cotton and 3% spandex. The garment comes in blush/pink and has a lace decoration strip around the hood opening. There is a white drawstring inside the hood lining that surrounds the face. There is a zipper on the front with a pocket on each side. The pocket openings and sleeves are decorated with a lace strip. The name Just Fab Girls is sewn into the label of the neck. There is also a label sewn into the side seam that reads “RN #137339” and “Made in China.”

Incidents/Injuries

None reported (more…)

Recall Summary

Name of product: WeThePeople Envy BMX bicycles and Eclat Aeon cranksets

Hazard:

The left end of the bicycle crankset spindle can break, posing a fall hazard to the rider.

Consumer Contact: QBP toll-free at 844-610-7484 from 8 a.m. to 6 p.m. CT Monday through Friday or online at www.qbpbmx.com and click on the Recall Information tab for more information.

Report an Incident Involving this Product

Recall Details

In conjunction with

Health Canada Logo

Units

About 70 bicycles and about 170 cranksets (in addition, about 40 bicycles and about 40 cranksets were sold in Canada)

Description

The recall involves WeThePeople Envy BMX bicycles and aftermarket ECLAT Aeon BMX cranksets. The Envy BMX bicycles have a 20.6 or 21 inch chromoly frame, painted dark gold. The bicycle bottom bracket has an “ENVY20.6” or “ENVY21” stamp. The ECLAT Aeon BMX cranksets are the gears at the front of the bicycle chain with pedals attached to the outer ends. The cranksets have a steel, two-piece construction. Printed on the left side of the spindle is ESS Eclat 22mm” and next to the pedal, on the crank arm is “Aeon.” Printed on the inside of the crank arm is “Eclat Germany” followed by the crank arm length “170mm” or “175mm.”

Incidents/Injuries

WeThePeople has received five reports of the crankset spindles breaking. No injuries have been reported. (more…)

Recall Summary

Name of product: Ceramic Mugs

Hazard:

Hot liquids can seep through hairline cracks, posing a burn hazard.

Consumer Contact: Lighthouse toll-free at 888-477-4031 from 10 a.m. to 6 p.m. ET Monday through Friday, email CustomerService@LCPgifts.com or online at www.LCPgifts.com and click on Recall Notice for more information.

Report an Incident Involving this Product

Recall Details

Units

About 4,400

Description

The two recalled ceramic mugs are the Pastor’s Wife model #18208, and the Serve with Gladness model #18209. The Pastor’s Wife mug is cream color on the outside and teal on the inside with the phrase “Pastor’s Wife” on one side and “We Always Thank God and Pray For You” on the other side. The Serve with Gladness mug is cream color inside and outside with the phrase “Serve with Gladness” on one side and “Anyone who loves is a child of God” inside a multicolored floral arrangement on the other side. Model number 18208 or 18209 is printed on a UPC sticker on the bottom of the mug.

Incidents/Injuries

The firm received a report of one incident. No injuries. (more…)

Recall Summary

Name of product: Heat-activated fire alarm

Hazard:

A defective fusible link sensor (fuse) on the fire alarm can cause the alarm to fail to alert consumers of a fire.

Consumer Contact: Sure Signal Products toll-free at 855-202-3083 from 8 a.m. to 5 p.m. PT Monday through Friday or at www.SureSignalProducts.com and click on CPSC Heat Sensor Recall in the upper right of the page for more information.

Report an Incident Involving this Product

Recall Details

Units

About 375,000

Description

This recall involves Sure Signal Products heat-activated fire alarms sold under the following brand names and models:  DeTech FST2004H, MasterGuard QR50, Responsive TR70-R and Thermalink QR50. They are white, round and measure about 7 inches in diameter. The alarms have a round fuse at the center. The fuse is white or chrome and about 1.5 inches in diameter, and has a temperature rating of 117°F or 136°F.  The alarms were manufactured from January 1, 2004 through July 1, 2015. Date codes are listed in a YYDDD format and range from 04001 through 15182. The alarm’s model is printed on a label on the back of the alarm. SSP, the temperature rating and the date code can be found on the back of the fuse.

Incidents/Injuries

None reported (more…)

For Immediate Release

October 27, 2015

Contact

Consumers

seafood@olebobs.com
 (360) 642-4332

Firm Press Release

OleBob’s Seafoods of Ilwaco WA is voluntarily recalling ALL canned tuna and canned salmon products with a code starting with “OC” because it has the potential to be contaminated with Clostridium botulinum, a bacterium that can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

** There have been no reported cases of illness to date. ** (more…)