Consumer Lawyers

Archive for January, 2013|Monthly archive page

Voluntary Worldwide Field Corrective Action Issued for the T-piece Circuit used on GE Healthcare’s Giraffe and Panda

In Uncategorized on January 8, 2013 at 3:24 pm

GE Healthcare initiated a voluntary worldwide field correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. The T-piece circuits affected by this recall are sold under the following part numbers and contain a red inspection stamp (those containing a blue inspections stamp are NOT affected by this recall):

  • M1091335 Kit, Circuit, T-Piece Disposable, 10 pack
  • M1091316 Kit, Circuit, T-Piece Disposable, W MASK Size 0, 10 pack
  • M1091365 Kit, Circuit, T-Piece Disposable, W MASK Size 1, 10 pack

The T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units may impact patient safety. The issue occurs when the T-piece circuit is not able to achieve maximum PIP (Peak Inspiratory Pressure) of 45 +/- 5 cmH[2]O as measured by the built-in Airway Pressure Manometer during the pre-use checkout procedure. The built-in Airway Pressure Manometer of the resuscitation system is not affected by this issue and will accurately display airway pressure. Clinicians should always use the airway pressure manometer to verify Peak Inspiratory Pressure (PIP). The affected units were manufactured from September 10, 2009 to May 10, 2012.

GE Healthcare initiated the field correction on June 26, 2012, and began notifying customers with affected units through an Urgent Medical Device Correction letter and follow up has been conducted to confirm their receipt of the letter. Through these efforts, approximately 84% of identified customers have confirmed receipt of the safety instructions provided and have also confirmed all affected product has been returned or destroyed. The remaining unconfirmed customers are being contacted directly to resolve and close the issue as soon as possible. Customers have been directed to NOT use the T-piece circuit with the part numbers listed above and to isolate all affected product. To date, no patient injuries have been reported with this issue.

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Southwest Ice Cream Specialties Conducts Voluntary Recall of ShurFine® Brand “Creamery Select Premium Ice Cream Dulce de Leche”

In Uncategorized on January 8, 2013 at 3:23 pm

Southwest Ice Cream Specialties is voluntarily recalling ShurFine Brand “Creamery Select (Premium Ice Cream) Dulce de Leche” Ice Cream (1.75 quarts, 1.66L) because it may contain praline pecan ice cream, which contains wheat, soy and pecans. The product is packed with a ShurFine Praline Pecan lid, but bears the Dulce de Leche product labeling on the carton. While no ShurFine product has been linked to any illness related to allergens at this time, Southwest Ice Cream Specialties is taking this precautionary measure because the ice cream inside the carton contains pecans, soy and wheat that are not declared on the packaging.

To date, no complaints or reactions have been reported. People who have an allergy or severe sensitivity to pecans, soy and/or wheat run the risk of serious or life-threatening allergic reaction if they consume this product.

This product is produced by the Southwest Ice Cream Specialties processing facility in McKinney, Texas, and is sold at various retail outlets under the ShurFine brand name.

Size Name Flavor UPC # Date Plant Code
1.75 quarts (1.66L) “scround” container ShurFine “Creamery Select” Premium Ice Cream Dulce de Leche carton with incorrect product and “ShurFine Praline Pecan” lid 015400224840 Best By NOV 8, 2014 48-3202-F

 

The affected product has a “Best By” date of November 8, 2014, and was sold by retailers in Arizona, Arkansas, Colorado, Kansas, Oklahoma, New Mexico and Texas. The carton carries the above referenced Universal Product Code (UPC) and plant code 48-3202-F.

LifeVantage Corporation Announces Recall and Replacement of Select Lots of Protandim® Dietary Supplement

In Food Recalls on January 7, 2013 at 2:18 pm

LifeVantage Corporation (NASDAQ: LFVN) announced today that it is contacting affected independent distributors and other customers to voluntarily recall and replace bottles of its Protandim®, the Nrf2 Synergizer®, dietary supplement from the lots shown below. The Company is taking this action due to the possible inclusion of small metal fragments in the final product. The fragments were originally discovered in batches of turmeric extract, an ingredient in Protandim® that was purchased from a third party supplier.

Protandim is packaged in a cylindrical blue bottle and contains thirty caplets per bottle. The potentially affected Protandim® lot numbers are shown below. The lots shown below were distributed in the United States and Japan between July and November 2012. Lot numbers are located on the left side of the product label when looking at the front of the label, directly above the RFID scan bar.

 

Lot# Expiration Date
12-0258 7/2/2015
12-0259 7/3/2015
12-0292 7/9/2015
12-0294 7/11/2015
12-0295 7/12/2015
12-0304 7/18/2015
12-0306 8/16/2015
12-0307 8/17/2015
12-0373 8/21/2015
12-0382 9/21/2015

 

When the Company was alerted to this issue, it immediately isolated affected product and began working with its third party manufacturers, suppliers and industry experts to mitigate any health risk potential. After consulting with medical experts, the Company believes that these materials pose no serious risk to consumers’ health. Furthermore, the Company has not received any report of a health problem related to this issue.