FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

H.L. Bouton Recalls Emergency Eye Wash and Eye/Face/Body Wash Because of Potential Non-Sterility

NEWS RELEASE



Contact:  Gary Sullivan
          (508) 759-8000

For Immediate Release

H.L. Bouton Recalls Emergency Eye Wash and Eye/Face/Body Wash Because of Potential Non-Sterility

Buzzards Bay, MA - September 27, 2000 - H.L. Bouton is voluntarily recalling all lots of Eyewash, Emergency Eye/Face/Body Wash, Eyewash Concentrate and Normal Saline. The products may not be sterile and could represent a serious health hazard.

The products are marketed under the Lavoptik, Zee Medical and Rapid Clear labels. The Eyewash and Emergency Eye Wash/Face/Body/Wash are in 6 oz., 16 oz., and 32 oz., 128 oz. and 5 Qt. sizes. The Saline Solution is a 16 oz. size. The Eyewash Concentrate is in 70 oz., and 180 oz. sizes.

A complete list is as follows:

Lavoptik Brand manufactured by H.L. Bouton:

  1. Lavoptik Emergency Eye/Face/Body/Wash in 16 oz. and 32 oz. sizes.
  2. Lavoptik Eye Wash in 6 oz.
  3. Lavoptik Eye Wash Concentrate in 70 oz. and 180 oz. sizes.

RapidClear Brand distributed by Sellstrom, Palatine, IL:

  1. RapidClear Eye Wash in 16 oz., 32 oz. and 128 oz. size
  2. RapidClear Eye Wash Concentrate in 180 oz.

Zee Brand distributed by Zee Medical, Irvine CA

  1. Zee Protector II Refill Eye Wash Solution in 5 Qt. size
  2. Normal Saline Solution in 16 oz.

The products are distributed Nationwide through industrial distribution channels.

For over 60 years Bouton has prided itself in only selling products of the highest quality.

While Bouton has received no reports of consumer complaints or injuries from these products, there is the potential that this could represent a serious health hazard. Bouton will not sell any product that could in any way be deemed to pose any risk to users.

The firm is requesting users to discontinue use, and return or dispose of products.

The firm may be contacted at 1-508-759-8000.with any questions regarding this recall.

Office of Public Affairs
Web page created by tg 2000-SEP-27.