Stryker slips on Sage Products recall

Stryker (NYSE:SYK) shares slipped today after the medical device company said it’s recalling some of the products sold by subsidiary Sage Products and narrowed its outlook for the rest of the year. Kalamazoo, Mich.-based Stryker paid $2.7 billion in April 2016 for Sage and its line of products designed to prevent so-called “never events.” But it wasn’t long before problems emerged with some of those products; by August Sage had expanded an existing recall of impregnated cloth topical skin products over contamination issues with the bacteria Burkholderia cepacia. That recall covered the Comfort Shield barrier cloths, incontinence clean-up cloths, M-care meatal cleansing cloths, Comfort Bath cleansing washcloths and 0.2% chlorhexidine gluconate cloths. Last month the FDA sent Sage a warning letter about continuing problems with B. cepacia contamination; today Stryker said it’s recalling some lots of the oral care products containing solutions manufactured by the third party, distributed between July 2015 and this month. “The recall is being initiated due to a potential for cross-contamination of oral care solutions manufactured by the third party on equipment shared with non-pharmaceutical products,” the company said, noting that it received no reports of serious adverse events and some reports of “minor irritation and allergic reaction.” Stryker said it stopped doing business with the supplier and that Sage has begun maki...
Source: Mass Device - Category: Medical Devices Authors: Tags: Hospital Care Recalls Regulatory/Compliance Sage Products Stryker Source Type: news