Wednesday, September 16, 2009

FDA Warns Users of Evenflo Breast Pumps; Evenflo Responds

In a warning letter dated August 25, 2009, the FDA stated they found violations at two plants that make Evenflo breast pumps. The breast pumps referenced are sold under the "Comfort Select" brand name.

During the inspections, the FDA found Evenflo was not in compliance with two of the FDA's manufacturing practice rules.  These included "failure to review and evaluate all complaints" and failure "to establish medical device reporting procedures for your breast pumps."

The agency stated that it reviewed 37 complaints. 18 of them were no investigated. At least three of these complaints related to women receiving an electrical shock when using the breast pumps.

Response from an Evenflo representative- 9/17/09

Since the inspection, Evenflo has provided the FDA with several updates on how the company is enhancing its internal written procedures and the FDA has been satisfied with Evenflo’s responses to most of the observations. At the end of August, the FDA informed Evenflo that several matters remained open but Evenflo expects to respond to those within the next week, and are confident that they will be able to resolve these matters by working with the FDA.

In regard to complaints concerning electrical shock, EvenFlo has investigated to the extent that information or the product was available to the company, and have provided information to the FDA regarding their investigation. The FDA has determined their response to be adequate.

"Safety is our core mission at Evenflo, and we are confident that the Comfort Select is safe for moms to use," states Don Huber, Director, Product Integrity at Evenflo.

Thank you, Evenflo, for taking the time to address the concerns of moms.

[Read more]
[Read FDA Warning Letter]

 Soure: WSJ Online