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Daily Dose

Rotarix Vaccine Temporarily Suspended

The FDA suspends Glaxo Rotarix vaccine I received the CDC Health Alert yesterday afternoon notifying physicians to “temporarily suspend the usage of GlaxoSmithKline (GSK) Rotarix (rotavirus) vaccine. Rotarix was licensed for use in 2008 to prevent rotavirus disease, which typically causes fever, vomiting and diarrhea in infants and young children.

Prior to this Merck’s vaccine RotaTeq had been licensed for us in 2006. Both of these vaccines are given orally. Both RotaTeq and Rotarix were found to prevent serious rotavirus illness and hospitalizations for dehydration. The GSK product, Rotarix, which is a “live attenuated” vaccine, has been found to contain DNA from porcine circovirus type 1 (PCV 1). PCV 1 virus is not known to multiply in human cells or to cause illness.  According to the FDA, “all available evidence indicates that there had been no increased risk to patients who have received this vaccine”.  The GSK vaccine, Rotarix, is made in a different manner than the Merck vaccine RotaTeq.  Preliminary studies by the FDA on RotaTeq vaccine have not shown the presence of PCV 1 DNA. Preliminary data reported to the FDA  by GSK related to PCV 1 being in the vaccine seems to suggest that it has been present since the early stages of the vaccine’s development.  Studies on Rotarix, both before and after the approval of the vaccine, have shown it to be extremely safe and no unusual adverse events have been reported.  At the same time, the vaccines that have been given are presumed to be effective. In the interim, while futher studies are being completed, it is recommended that children continue to receive RotaTeq vaccine.  The FDA plans to convene an advisory committee to look into how the DNA components came to be present in this vaccine. They are also going to look into the use of new techniques for identifying viruses in vaccines.  After this meeting, the FDA will make further recommendations about the use of rotavirus vaccines in the United States. This recall was limited to the United States, and children in other areas or the world are continuing to receive Rotarix, as the available evidence suggests that the benefits of the vaccine outweigh the risks, especially in areas where rotavirus disease causes severe disease and even deaths. I would not be alarmed if my baby had received this vaccine as it does not cause disease in animals or humans.  I would also complete my child’s vaccine series with the Merck product which is available.  We will all have to stay tuned for further details,  but this should also make parents aware that the safety of vaccines continues to be monitored, even after they have been approved. That's your daily dose for today.  We'll chat again tomorrow! Send Dr. Sue your question now!

Your Baby

Recall: Oball Baby Rattles Due to Choking Hazard

1:30

About 680,000 Kids ll Inc. Oball baby rattles have been recalled due to choking hazards.

This recall involves Oball Rattles in pink, blue, green and orange with model number 81031 printed on the inner surface of one of the plastic discs and on the packaging. The balls have 28 finger holes and measure four inches in diameter.

Embedded in the rattles are a clear plastic disc with all orange beads and two clear plastic discs with beads of varying colors on the perimeter.

Only rattles with date codes T0486, T1456, T2316, T2856 and T3065 located on a small triangle on the inner surface of the rattle are included in the recall.

The first three numbers represent the day of the year and the last digit represents the year of production.      

The firm has received 42 reports of the plastic disc breaking releasing small beads including two reports of beads found in children’s mouths and three reports of gagging.

Consumers should immediately take these recalled rattles away from young children and contact the firm to receive a full refund.

The rattles were sold at Target, Walgreens, Walmart and other retailers nationwide and online at Amazon.com, Babyhaven.com, Diapers.com, ToysRUs.com, Walgreens.com and other online retailers from January 2016 through February 2017 for between $5 and $7.  

Consumers can contact Kids II toll-free at 877-243-7314 from 8 a.m. to 5 p.m.  ET Monday through Friday or visit www.kidsii.com and click on “Recalls” at the bottom of the page for more information.

Story source: https://www.cpsc.gov/Recalls/2017/Kids-II-Recalls-Oball-Rattles

Your Child

Recall: MZB Children’s Watches Due to Rash, Chemical Burns

1:00

They are cute, keep time and appeal to children who want to own a watch. But, these watches have a defect that can expose children to serious skin irritations including chemical burns.

Nearly two million MZB Children’s “Light Up” Watches have been recalled because the case-back of the watch can detach and expose the interior to water posing a risk of skin irritation, redness, rashes or chemical burns.

This recall involves 303 styles of “Light Up” watches that are identified by style number. A complete list of the serial numbers is listed on the firm’s website http://www.regcen.com. The watches have a flexible plastic wristband sold in multiple colors including pink, pink with white snowflakes, green, blue and navy blue. “MZB” and the style number are printed on the case-back of the watches.

The firm has received 11 reports of skin irritations or chemical burns. Six of these consumers have required medical treatment.

The watches were sold at Kmart, Kohl’s, Walmart and other retailers nationwide from October 2012 through June 2015 for between $5 and $20.

Consumers should immediately take the recalled watches away from children and contact MZB for a refund.

MZB can be reached by calling their toll free number at (888) 770-7085 from 8 a.m. to 7 p.m. ET Monday through Friday or online at www.mzb.com and click on Product Safety Notice tab at the top of the homepage for more information.

Source: http://www.cpsc.gov/en/Recalls/2015/MZB-Recalls-Childrens-Watches/

Your Baby

Recall: Tommee Tippee Electric Bottle and Food Warmers Due to Fire Hazard

1:30

Mayborn USA is recalling about 255,000 Tommee Tippee electric bottle and food warmers because they could overheat and catch fire, according to the U.S. Consumer Product Safety Commission.

This recall involves Tommee Tippee® Closer to Nature® electric bottle and food warmers, sold separately or as an accessory with the Complete Starter Kit or the All in One Newborn Set. The bottle and food warmer is white with a gray adjustable control dial located next to the on/off light. Tommee Tippee is stamped in gray on the front of the unit. It measures about 5 inches high, 5 ½ inches wide and 5 inches long. Bottle and food warmers included on this recall have “Min” or “0” stamped on the left-hand side of the control dial and have the UL logo and a six alpha-numeric batch code that begins with a number and ends with “GY” stamped on the underside. Consumers should visit www.tommeetippee.us/bottle-warmer to complete the free replacement registration form.

The firm has received six reports of bottle and food warmers overheating, melting, smoking and catching on fire; which resulted in $16,000 in property damage.

Consumers should immediately unplug and stop using the recalled bottle and food warmers and contact Mayborn for free replacement warmers.  

The product was sold at merchandise stores including Baby Depot, Baby Heaven, Bealls Outlet, BuyBuy Baby, CVS, Giant, Ideal Baby and Kids, Kohl’s, Marco Baby, Marshalls, Meijer, Ross Stores, Sam’s Club, Target, TJ Maxx, Toys R Us, Walgreens and Wal-Mart nationwide and online at Amazon.com, Diapers.com, Drugstore.com and Quidsi.com from July 2011 through April 2016 for about $21 for the individual bottle and food warmer and about $120 for the starter kit or newborn set.

Consumers can contact Mayborn online at www.tommeetippee.us and click on the recall button at the bottom of home page or toll-free at 844-340-3420 from 9 a.m. to 5 p.m. ET Monday through Saturday for more information.

This Mayborn recall follows another recent recall from the company. In May 2016, over 3 million Tommee Tippee Sippee Spill-Proof Cups were recalled due to the possibility of mold build-up in the removable, one-piece white valve.

Mayborn USA had received 3,066 reports of mold in the removable, one-piece, opaque valve of the Sippee cups, including 68 reports of children experiencing diarrhea, vomiting or other symptoms associated with drinking from a cup with mold in the valve.

Story sources: https://www.cpsc.gov/en/Recalls/2016/Tommee-Tippee-Electric-Bottle-and-Food-Warmers-Recalled-by-Mayborn-USA/

http://www.cpsc.gov/en/Recalls/2016/Tommee-Tippee-Sippee-Cups-Recalled-by-Mayborn-USA/

Parenting

Recall: Cracker Barrel’s Animated Toy Monkey Due to Burns

1:45

Giggles International is recalling about 13,000 of their Animated Sing Along Monkey toy due to the possibility that the battery compartment can reach temperatures up to 230 degrees Fahrenheit, posing a burn hazard for children.

This recall involves Giggles International Animated Sing-Along Monkey toys. The monkey is made of brown and beige plush material and is about 9 inches tall. The toy is designed to hold a songbook titled "5 Little Monkeys" and to sing the song when activated. A red music note is on the bottom of the monkey's right foot and the face of a child with its hands covering its eyes are on the bottom of the money's left foot. Recalled sing-along monkeys were manufactured between 6/7/2014 and 7/5/2014 and have batch code GP1410028.  

The manufacture date in the M/D/YYYY format and batch code are printed on the bottom of a white fabric label attached near the base of the monkey's tail. The monkey toys came in a tan colored box with words "Animated Sing-Along Monkey," "Sing along with me!" and "I play peek-a-boo with you!" on the front. The age advisory "For ages 3+" and the warning that batteries are included are also on the front of the box.

Giggles International has received two reports of toys overheating and melting their battery compartments.

The toy is sold exclusively at Cracker Barrel Old Country Stores nationwide from September 2014 to October 2014 for about $25.

Consumers should immediately take the animated monkey away from children, remove the batteries and return the toy to any Cracker Barrel Old Country Store or contact Giggles International for a full refund.

You can contact Giggles International at (800) 738-6018 from 9 a.m. to 6 p.m. ET Monday through Friday or online at www.LoveMyGiggles.com and click on Recall at the top of the page for more information.

Toy monkey recall

Your Toddler

Ikea Recalls 29 Million Chests and Dressers After More Children Die

2:00

The U.S. Consumer Product Safety Commission (CPSC), in cooperation with IKEA North America, of Conshohocken, Pa., is announcing the recall of all chests and dressers that do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).  The recalled children’s chests and dressers are taller than 23.5 inches and adult chests and dressers are taller than 29.5 inches.  The 29 million units of recalled chests and dressers include: MALM 3-drawer, 4-drawer, 5-drawer and three 6-drawer models and other children’s and adult chests and dressers.  The recalled chests and dressers are unstable if they are not properly anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or serious injuries to children.

 On July 22, 2015, CPSC and IKEA announced a repair program for the chests and dressers that included a free wall-anchoring repair kit for the MALM chests and dressers and other IKEA chests and dressers. Two tragic fatalities involving MALM chests and dressers occurred prior to the announcement of the repair program:

·      In February 2014, a 2-year-old boy from West Chester, Pa. died after a 6-drawer MALM chest tipped over and fatally pinned him against his bed.

·      In June 2014, a 23-month-old boy from Snohomish, Wash. died after he became trapped beneath a 3-drawer MALM chest that tipped over. 

Subsequent to the July 2015 announcement, CPSC and IKEA learned of additional tip-over incidents, including a February 2016 incident in which a 22-month-old boy from Apple Valley, Minn. died when a MALM 6-drawer chest fell on top of him. 

 None of the chests or dressers in the above-listed incidents had been anchored to the wall.  In addition to the three deaths, IKEA received reports of 41 tip-over incidents involving the MALM chests and dressers, resulting in 17 injuries to children between the ages of 19 months and 10 years old.

 The MALM chests and dressers are constructed of particleboard or fiberboard and are white, birch (veneer), medium brown, black-brown, white stained oak (veneer), oak (veneer), pink, turquoise, grey, grey-turquoise, lilac, green, brown stained ash (veneer), and black.  A 5-digit supplier number, 4-digit date stamp, IKEA logo, country of origin and “MALM” are printed on the underside of the top panel or inside the side panel. 

 Since 1996, IKEA chests and dressers have been labeled to identify IKEA, the model name and the manufacturing date.

 The recalled MALM chests were sold from 2002 through June 2016 for between $70 and $200. 

 Recalled MALM Chest and Drawers:

·      MALM 3 – Sold 10/2002 to 6/2016

·      MALM 4 – Sold 6/2002 to 6/2016

·      MALM 5 -  Sold 10/2002 to 4/2006

·      MALM 6-  Sold 6/2002 to 6/2016

·      MALM 6 LONG – Sold 11/2002 to 6/2016

·      MALM 6 – Sold 4/2006 to 6/2016

IKEA also received 41 reports of tip-overs involving chests and dressers other than MALMs, resulting in the deaths of three children and 19 injuries to children:

·      In July 1989, a 20-month-old girl from Mt. Vernon, Va. died after  an unanchored GUTE 4-drawer chest tipped over and pinned her against the footboard of a youth bed.

·      In March 2002, a 2½-year-old boy from Cranford, N.J. died after an unanchored RAKKE 5-drawer chest tipped over and fatally pinned him to the floor.

·      In October 2007, a 3-year-old girl from Chula Vista, Calif. died after a KURS 3-drawer chest tipped over and fatally pinned her to the floor.  It is unknown as to whether the dresser was anchored or not.

Other recalled Chest and Drawers:

Most of the non-MALM chests and dressers included in this recall are listed on the IKEA website at www.IKEA-USA.com/recallchestsanddressers.

 Since 1996, IKEA chests and dressers have been labeled to identify IKEA, the model name and the manufacturing date.

 CPSC and IKEA are urging consumers to inspect their recalled IKEA chests and dressers to ensure that they are properly anchored to the wall.  Chests and dressers should be properly anchored to the wall whether or not they meet the ASTM standard.  Consumers should move any unanchored chests and dressers into storage or other areas where they cannot be accessed by children until the chests and dressers are properly anchored to the wall or removed from the home.

To receive a refund or free wall-anchoring kit for IKEA chests and dressers listed above, visit an IKEA retail store, go to www.IKEA-USA.com/recallchestsanddressers , or call 866-856-4532 anytime.

A child dies every two weeks and a child is injured every 24 minutes in the U.S. from furniture or TVs tipping over, according to CPSC data.

Remedy

Consumers should immediately stop using any recalled chest and dresser that is not properly anchored to the wall and place it into an area that children cannot access.  Contact IKEA for a choice between two options: refund or a free wall-anchoring repair kit.

Consumers are entitled to a full refund for chests and dressers manufactured between January 2002 and June 2016. Consumers with chests and dressers manufactured prior to January 2002 will be eligible for a partial store credit. 

Consumers can order a free wall-anchoring repair kit. Consumers can install the kit themselves or IKEA will provide a one-time, free in-home installation service, upon request. Consumers can reorder the kits throughout the life of their chest and dresser.

Story Source: http://www.cpsc.gov/en/Recalls/2016/IKEA-Recalls-29-Million-MALM-and-Other-Models-of-Chests-and-Dressers/

 

 

Your Baby

IKEA Recalls 169,000 Crib Mattresses

1:30

Swedish furniture maker IKEA is recalling about 169,000 of their VYSSA crib mattress because of the risk that infants can become trapped between the mattress and the crib.

The firm has received two reports of infants becoming entrapped between the mattress and an end of the crib. The children were removed from the gap without injury.

The mattresses were sold exclusively at IKEA stores and online from August 2010 to May 2014 for about $100.00.

This recall involves IKEA VYSSA style crib mattresses with the following five model names:

·      VACKERT

·      VINKA

·      SPELEVINK

·      SLÖA

·      SLUMMER.

The involved mattresses were manufactured on May 4, 2014 or earlier. An identification label attached to the mattress cover has the date of manufacture in Month-DD-YYYY format and the VYSSA model name. A gap between the mattress and crib ends larger than two-finger width is an indication of the defective mattress.

Consumers should inspect the recalled mattress by making sure there is no gap larger than the width of two fingers between the ends of the crib and the mattress. If any gap is larger, customers should immediately stop using the recalled mattresses and return it to any IKEA store for an exchange or a full refund.

Consumers can contact IKEA toll-free at (888) 966-4532 anytime or online at www.ikea-usa.com and click on the recall link at the top of the page for more information.

Source: http://www.cpsc.gov/en/Recalls/2015/IKEA-Recalls-Crib-Mattresses/

Your Toddler

Safety 1st Recalls Décor Wood Highchairs Due to Falls

1:30

Dorel Juvenile Group, of Columbus, Ind., is recalling about 35,000 Safety 1st Wood Décor highchairs because a child can remove the highchair’s tray, posing a fall hazard.

Safety 1st has received 68 reports of children removing the trays and 11 reports of injuries such as lacerations, chipped teeth and bruises.

The highchairs were sold at Babies R US and Toys R Us retail stores nationwide and online at www.Amazon.com, www.BabiesRUs.com, www.ToysRUs.com and www.Walmart.com and other online retailers from May 2013 through May 2015 for about $120.

This recall includes Safety 1st Wood Décor highchairs in three models: HC144BZF (Casablanca), HC229CZF (Gentle Lace) and HC229CYG (Black Lace). The model numbers are printed under the highchair seat. These A-frame black wood highchairs have a removable fabric, black and white print seat pad with a blue or pink border on the top and bottom of the seat pad. The highchairs have a white plastic, detachable tray with a cone-shaped center divider that fits between a child’s legs. “Safety 1st” is printed on the front center of the tray.

Consumers should immediately stop using these recalled highchairs and contact the firm to receive instructions on receiving a new tray with labels.   

Consumers can contact Safety 1st toll-free at (877) 717-7823 from 8 a.m. to 5 p.m. ET Monday through Friday, email at decorwoodhighchair@djgusa.com or online at www.safety1st.com and click on “Safety Notices” at the top of the page for more information.

Source: http://www.cpsc.gov/en/Recalls/2016/Safety-1st-Recalls-Decor-Wood-Highchair/

 

Your Baby

Recall: More Than 217,000 Instep and Schwinn Jogging Strollers

1:30

Pacific Cycle is working with the U.S. Consumer Product Safety Commission (CPSC) in a recall involving more than 217,000 Instep and Schwinn swivel wheel jogging strollers.

This recall includes single and double occupant swivel wheel jogging strollers that have a quick release mechanism for removing and re-attaching the front wheel. Instep Safari, Instep Grand Safari, Instep Flight, Schwinn Turismo and Schwinn Discover Single and Double Occupant Swivel jogging strollers with the following model numbers are affected. These models come in a variety of colors. The model number is located on the inside of the metal frame above the rear right wheel.

Instep Safari

 

Single

Instep Grand Safari

Single

Instep Safari

 

Double

Instep Grand Safari

Double

Instep Flight 

 

Single

11-AR178

11-AR182

11-AR220B

11-AR282

11-AR101AZ

11-AR179

11-AR183

11-AR224

11-AR283

 

11-AR180

11-AR184

11-AR278

11-AR284

 

11-AR181

11-AR-192

11-AR279

11-AR292

 

11-AR240B

11-AR193

11-AR280

11-AR293

 

11-AR245

 

11-AR281

 

 

11-AR250

 

11-AR290

 

 

11-AR255

 

11-AR291

 

 

11-AR700A

 

11-AR340B

 

 

111-AR750

 

11-AR345

 

 

11-AR178DS

 

11-AR350

 

 

11-AR179DS

 

11-AR355

 

 

11-AR120B

 

 

 

 

11-AR190

 

 

 

 

11-AR191

 

 

 

 

 

 

 

 

 

 

 

Instep Flight

 

— Double

Schwinn Turismo

 

 Single

Schwinn Turismo

 

Double

Schwinn Discover

 

Single

Schwinn Discover

 

Double

11-AR201AZ

13-SC113

13-SC213

13-SC105AZ

13-SC205AZ

11-AR301AZ

13-SC114

13-SC214

 

 

 

13-SC116

13-SC216

 

 

 

13-SC117

13-SC217

 

 

The front wheel can become loose and detach, posing crash and fall hazards.

The firm has received 132 reports of the front wheel becoming loose or unstable, resulting in 215 injuries, including head injuries, sprains, lacerations, bumps, bruises, and abrasions.

Consumers should immediately stop using the recalled jogging strollers and contact Pacific Cycle to obtain a repair kit to secure the front wheel. The repair kit includes a replacement mechanism for securing the front wheel that uses a traditional screw on/off method of attachment instead of the quick release lever method of attachment shipped with the product, as well as new warning labels. Consumers should not return the jogging strollers to retailers where purchased. A repair video is available at www.pacific-cycle.com/safety-notices-recalls/.

These models were sold at small retailers nationwide and online at Amazon.com, Target.com, Toys-R-Us.com, Walmart.com and other online retailers from January 2010 through June 2016 for between $130 and $350.

To see photos of the strollers, click on the website below. 

Story source: http://www.cpsc.gov/en/Recalls/2016/Pacific-Cycle-Recalls-Swivel-Wheel-Jogging-Strollers/

 

 

 

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