I recently reviewed an AWESOME product called Playful Trayful (see here for the review). Unfortunately, just a few days after the product was ready to launch, disaster stuck. Here is a letter direct from their PR firm:
"My client Playware Products makes a brand new children's food try called Playful Trayfuls, and after a year of research came up with the best possible substance to make their trays out of: polycarbonate. It's dishwasher-safe, microwave-safe, shatterproof, made of the same stuff millions of school lunch trays are made of.
After months of delays, packaging design interruptions, Chinese New Year and other normal holdups that it seems all manufacturers experience, the much-anticipated first shipment of 10,000 trays arrived from China on Monday. The trays were tested for lead content, phthalates and microwave safety and passed all.
On Thursday,(yesterday) this story comes out. And since the trays do contain BPA, the company has withdrawn its product from sale, just four days after they finally got their shipment.
"We just cannot bear to sell a product for children that could potentially be bad for humans," says Dave Goldenberg, one of the two heartbroken dads from Connecticut who designed the trays. Goldenberg and his partner are two advertising execs who came up with this product as a side venture.
The trays are safe from the US government's point of view, but Goldenberg and his partner would rather err on the side of super caution: "We'll put the kids first every time. That's why we're not rich," he said. They are flat out of funds, having invested all of their life savings into the product at this point, so they are effectively out of business four days after they started. They need an investor to see that there's an opportunity for making the product out of a new substance!"
I, for one, am extremely impressed with these men, who have put children first, to their own detriment. I publish this today, just in case anyone with funds to invest is reading. What a wonderful opportunity, just waiting for the right person or persons.
Thumbs up Playware Products! It's nice to see someone do the right thing in this day and age of corporate greed.
Showing posts with label product recalls. Show all posts
Showing posts with label product recalls. Show all posts
Monday, April 21, 2008
Thursday, May 31, 2007
Product Recall
Great, just great. The exact solution I use.
Complete MoisturePLUS recall- posted 5/30/07
URGENT MEDICAL DEVICE RECALL NOTICECOMPLETE® MoisturePLUS™ CONTACT LENS CARE PRODUCTS
Manufactured by AMO
May 25, 2007
Dear Consumer:Advanced Medical Optics (AMO) has announced a voluntary recall of its Complete® MoisturePlusTM contact lens solutions products. The recall is being initiated because of concerns over eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections.
There is no evidence to suggest that today’s voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products, including AMO's family of hydrogen peroxide disinfecting solutions.
The U.S. Centers for Disease Control and Prevention (CDC) made data available to AMO showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePlusTM solution versus those who did not.
This recall is being conducted on a voluntary basis, in cooperation with the U.S. Food and Drug Administration (FDA).The incidence of AK infections in the United States has been estimated by CDC at approximately one to two cases per million contact lens users. Acanthamoeba is an organism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. AK infections are usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma.
If you are a contact lens wearer and have any of these symptoms, you should consult with your eye doctor: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. The symptoms, which can last several weeks to months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections but AK may eventually cause severe pain and possible vision loss with some patients requiring a corneal transplant, if untreated.
If you use Complete® MoisturePlusTM contact lens solutions products, please follow these steps:
Check to ensure that the COMPLETE product you have purchased is a Complete® MoisturePlusTM contact lens solutions product. This recall only pertains to Complete® MoisturePlusTM contact lens solutions products; all other COMPLETE products remain unaffected.
If you are using a Complete® MoisturePlusTM contact lens solutions product please discontinue use immediately and call 1-888-899-9183.
If you have used a Complete® MoisturePlusTM contact lens solutions product and are experiencing any problems with your eyes, consult your eye care practitioner immediately.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by call 1-800-347-5005 and to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, or by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
AMO has a 50-year heritage built on high safety and efficacy standards for our products. We are committed to protecting the trust eye care professionals and consumers place in our products and will take all necessary measures to ensure that our products remain safe and effective for the daily disinfecting of all contact lenses.
Complete MoisturePLUS recall- posted 5/30/07
URGENT MEDICAL DEVICE RECALL NOTICECOMPLETE® MoisturePLUS™ CONTACT LENS CARE PRODUCTS
Manufactured by AMO
May 25, 2007
Dear Consumer:Advanced Medical Optics (AMO) has announced a voluntary recall of its Complete® MoisturePlusTM contact lens solutions products. The recall is being initiated because of concerns over eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections.
There is no evidence to suggest that today’s voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products, including AMO's family of hydrogen peroxide disinfecting solutions.
The U.S. Centers for Disease Control and Prevention (CDC) made data available to AMO showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePlusTM solution versus those who did not.
This recall is being conducted on a voluntary basis, in cooperation with the U.S. Food and Drug Administration (FDA).The incidence of AK infections in the United States has been estimated by CDC at approximately one to two cases per million contact lens users. Acanthamoeba is an organism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. AK infections are usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma.
If you are a contact lens wearer and have any of these symptoms, you should consult with your eye doctor: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. The symptoms, which can last several weeks to months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections but AK may eventually cause severe pain and possible vision loss with some patients requiring a corneal transplant, if untreated.
If you use Complete® MoisturePlusTM contact lens solutions products, please follow these steps:
Check to ensure that the COMPLETE product you have purchased is a Complete® MoisturePlusTM contact lens solutions product. This recall only pertains to Complete® MoisturePlusTM contact lens solutions products; all other COMPLETE products remain unaffected.
If you are using a Complete® MoisturePlusTM contact lens solutions product please discontinue use immediately and call 1-888-899-9183.
If you have used a Complete® MoisturePlusTM contact lens solutions product and are experiencing any problems with your eyes, consult your eye care practitioner immediately.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by call 1-800-347-5005 and to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, or by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
AMO has a 50-year heritage built on high safety and efficacy standards for our products. We are committed to protecting the trust eye care professionals and consumers place in our products and will take all necessary measures to ensure that our products remain safe and effective for the daily disinfecting of all contact lenses.
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