Stryker Company Recalls Contaminated Cleansing Cloths

The disposable cloths contain a potentially dangerous antibiotic-resistant microbe.

Sage Products, acquired earlier this year by Stryker, has announced an expanded voluntary recall of its Comfort Shield Barrier Cream Cloths due to contamination with the bacteria Burkholderia cepacia.

Topical administration of a product with B. cepacia may cause life-threatening infections in patients whose bodies cannot fight disease and in hospitalized patients. Patients who have chronic lung conditions such as cystic fibrosis, are also at risk, according to a company statement and FDA.

The disposable cloths are pre-moistened to clean the skin of patients with incontinence and coat it with a 3% dimethicone barrier cream to seal out wetness, according to the website of the company, which Stryker acquired in April for $2.775 billion. The cloths are designed to offer one step to caregivers rather than using other wipes, lotions, creams, and deodorizers.

Sage is adding a second lot of the cloths to the recall, initiated July 29 for one lot. The company has notified its distributors and healthcare facilities in the United States by letter, instructing them to discontinue use and return the cloths to Sage. In addition to care facilities, Sage sells Comfort Shield Barrier Cream Cloths in drug stores and online.

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Sage declined to say how many units it is recalling, how the contamination occurred and how it was discovered. Stryker also declined to provide additional information.

No adverse events associated with the recalled products have been reported, and FDA has yet to issue a classification for the recall. The affected lots were distributed to customers between March 31 and June 8, 2016, and July 18 and July 19, 2016.

When Stryker announced the Sage acquisition in February, it described the Cary, IL–based company as a growing, $430-million-a-year business that makes and distributes products for oral care, skin preparation and protection, patient cleaning and hygiene, and turning and positioning of patients, as well as heel-care boots. Sage Products sales were up 13% in 2015. It is now part of Stryker’s medical division.

Sage’s portfolio of disposable products complement Stryker products, including ICU and hospital beds. In announcing the deal, Stryker executives said they see a great deal of potential in expanding Sage sales around the world, and leveraging Stryker’s existing relationship in hospitals.

Transmission of B. cepacia from contaminated medicines and devices is not a new problem.

In 2005, CDC was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash.

In 2004, CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex. Also in 2004, B. cepacia was linked to nosocomial infections among intensive care unit patients and associated with exposure to sublingual probes.

B. cepacia can also be spread to susceptible persons by person-to-person contact, contact with contaminated surfaces, and exposure in the environment.

Separately, CDC and FDA announced in June that they, along with multiple state and local health departments, were investigating a multistate outbreak of B. cepacia infections. Those infections, which have occurred primarily in ventilated ICU patients who do not have cystic fibrosis, have been preliminarily linked to liquid stool softeners containing docusate.

Until more information is available, CDC officials are recommending that health care facilities not use any liquid docusate products for patients who are critically ill, ventilated or immunosuppressed. Institutions housing patients with B. cepacia infection who do not have cystic fibrosis should sequester all liquid docusate products.