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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals 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.

Salus Corporation dba ICP Medical Issues Nationwide Recall of Shampoo Caps

Contact:
Salus Corporation dba ICP Medical
314-429-1000

FOR IMMEDIATE RELEASE -- Olivette, MO -- October 31, 2005 -- Salus Corporation dba ICP Medical of Olivette, Missouri, has voluntarily initiated a nationwide recall of all lot numbers of shampoo caps with conditioner because some of the product is contaminated with the bacteria Serratia marcescens. Serratia marcescens has the potential to cause severe and life-threatening illness, especially in those with a compromised immune system. To date, no adverse effects have been reported as a result of using these shampoo caps. The bacteria has the potential to cause wound infections and then gain access to the blood stream from infected wounds. Once in the blood stream the bacteria has the potential to cause a number of life-threatening complications. It also has the potential to cause sight-threatening eye infections, as well as a number of other health problems. Serratia marcescens is often resistant to many antibiotics making treatment of an infection potentially problematic. The shampoo caps may have been used in medical settings on patients that are immuno-compromised or have head wounds.

The shampoo caps were manufactured under three brand names: (1) The Salus Corporation dba ICP Medical brand name of CompleteBath (Reorder No. ICP095230); the brand name of ReadyBath, manufactured for Medline Industries, Inc., Mundelein, IL (Reorder No. MSC095230); and the brand name of No-Rinse, manufactured for No Rinse Laboratories, LLC, Centerville, OH (Reorder No. 02000). The shampoo caps are packaged 1 disposable cap per plastic bag. The plastic bag is labeled with the product name. The product is used as a method of cleaning the hair without the use of running water rather than using conventional shampooing methods.

The shampoo caps were distributed to health care facilities and institutions nationwide through Salus Corporation, Medline Industries, and No Rinse Laboratories. The product can also be purchased through the internet. Salus Corporation Corporation has notified their customers to arrange for return of the shampoo caps.

Salus Corporation voluntarily initiated the recall after learning complaints of odor had been received on the ReadyBath Shampoo Cap with Conditioner. Their investigation has revealed the potential source of the bacteria and has taken steps to correct the problem.

The shampoo caps should be returned to the point of purchase or by calling Salus Corporation dba ICP Medical at 314-429-1000. Health care facilities or consumers may contact Tom Huling, Vice President of Salus Corporation at 314-429-1000, ext. 226 for any further questions.

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