Stryker ’ s Sage Products expands med wipes recall over B. cepacia contamination concerns

Stryker‘s (NYSE:SYK) Sage Products subsidiary is expanding its voluntary worldwide recall to include lots of impregnated cloth topical skin products over contamination issues with the bacteria Burkholderia cepacia, according to an FDA notice. The recall includes Sage Products’ Comfort Shield barrier cloths, incontinence clean-up cloths, M-care meatal cleansing cloths, Comfort Bath cleansing washcloths and .2% chlorhexidine gluconate cloths. Use of the products contaminated with B. cepacia could cause serious infections in patients with compromised immune systems or in hospitalized patients which could be life threatening, according to an FDA notice. The company recalled products distributed between August 2014 and August 2016 across multiple supply lines including healthcare facilities and retailers in the U.S., Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates. The B. cepacia bacteria has been at the heart of other FDA recalls, including a number of benzalkonium chloride swabs and antiseptic wipes in 2012, a lot of Zicam extreme congestion relief and babywipes from multiple brands in 2014 and Diocto Liquid docusate sodium solution earlier this year. Sage Products said it is notifying customers with the products of the recall and advised customers to return the affected products to the company for credit. In April, Stryker said...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Hospital Care Recalls Sage Products Stryker Source Type: news

Related Links:

Publication date: Available online 18 March 2019Source: Actas Urológicas Españolas (English Edition)Author(s): C. Müller-Arteaga, J.E. Batista-Miranda, C. Zubiaur Libano, R. El Khoury Moreno, G. Morales Solchaga, J. Casas Nebra, M. Leva Vallejo, O. Gonzalez Garcia, C. Errando-Smet, S. Arlandis-GuzmanAbstractIntroduction and objectivesOlder patients with overactive bladder under antimuscarinic treatment are especially susceptible to cognitive impairment. The aim was to assess short term changes in cognitive function in elderly patients with overactive bladder treated with transdermal oxybutynin.Materials ...
Source: Actas Urologicas Espanolas - Category: Urology & Nephrology Source Type: research
Conditions:   Urinary Stress Incontinence;   Pain Interventions:   Drug: lidocaine 2% gel;   Drug: water soluble lubricant Sponsors:   Kristine Zinkgraf;   Medical College of Wisconsin;   WomenConnected Completed
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Abstract BACKGROUND: Chlorhexidine gluconate (CHG) has a broad-spectrum antimicrobial property that has proven to be effective in prolonging skin antisepsis and decreasing pathogens often seen in oncology units. OBJECTIVES: The aim was to reduce the incidence of central line-associated bloodstream infections in a hematology-oncology unit through the staff's continued adherence to the institution's protocol for CHG baths with wipes, and to identify barriers and the degree to which they interfered with optimal use of the CHG wipes. METHODS: The project focused on supporting staff and nurses by providing ed...
Source: Clinical Journal of Oncology Nursing - Category: Nursing Authors: Tags: Clin J Oncol Nurs Source Type: research
A survey of more than 650 women in the UK who had the controversial implant to treat their prolapse or urinary incontinence also revealed one in 20 are in such severe pain they regularly self-harm.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Introduction: The growing demand for esthetic dental procedures has resulted in the increased development of new restorative composite resins. The success of composite resin restorations depends on their color stability over time. The present study aimed to evaluate the effects of 0.2% chlorhexidine (CHX) and re-polishing on the color stability of nanofilled composite resins. Methods: This interventional, in-vitro study was conducted on 48 disk-shaped samples (diameters: 8×2 mm), which were prepared using Z350 (3M ESPE, USA) and Grandio (VOCO, Germany) A2 shade composite resins. The samples were divided into four gro...
Source: Journal of Dental Materials and Techniques - Category: Dentistry Source Type: research
A network meta-analysis suggests behavioral therapy may be as good as medication for treating urinary incontinence in women; the results confirm international guidelines.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Source Type: news
Conclusion: Most nonpharmacologic and pharmacologic interventions are more likely than no treatment to improve UI outcomes. Behavioral therapy, alone or in combination with other interventions, is generally more effective than pharmacologic therapies alone in treating both stress and urgency UI. Primary Funding Source: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42017069903). PMID: 30884526 [PubMed - as supplied by publisher]
Source: Annals of Internal Medicine - Category: Internal Medicine Authors: Tags: Ann Intern Med Source Type: research
We asked Dr Penelope Law, a consultant obstetrician and gynaecologist at Hillingdon Hospital and The Portland Hospital in London, to assess a selection. We then rated them.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Microinnovation: what paper towels have to teach us about medtech How can you double the efficiency of a paper towel? Turns out you don’t need to reformulate or make the paper thicker. Instead, you find a simple concept t...
Source: Mass Device - Category: Medical Devices Authors: Tags: News Well Plus 5 Source Type: news
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 ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Hospital Care Recalls Regulatory/Compliance Sage Products Stryker Source Type: news
More News: Bahrain Health | Burkholderia | Burkholderia Cepacia | Cardiology | Chlorhexidine | El Salvador Health | Heart | Honduras Health | Hospitals | Incontinence | Intensive Care | Medical Devices | Middle East Health | Skin