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MassDevice.com +5 | The top 5 medtech stories for August 23, 2017
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 - August 23, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Centurion Labs Issues Voluntary Nationwide Recall of Ninjacof (Lot # 200N1601) and Ninjacof A (Lot# 201NA1601) Products Due to Potential < em > Burkholderia Cepacia < /em > Contamination
Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 23, 2017 Category: Food Science Source Type: news

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 ...
Source: Mass Device - August 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Hospital Care Recalls Regulatory/Compliance Sage Products Stryker Source Type: news

FDA warns of potential contamination in multiple brands of drugs, dietary supplements
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 11, 2017 Category: American Health Source Type: news

FDA Warns Against Use of Any Liquid Product From PharmaTech FDA Warns Against Use of Any Liquid Product From PharmaTech
Lab tests have found Burkholderia cepacia contamination in PharmaTech's oral liquid docusate products, which has been linked to recent patient infections.News Alerts (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - August 9, 2017 Category: Intensive Care Tags: Infectious Diseases News Alert Source Type: news

Rugby Laboratories Issues Voluntary Nationwide Recall of Diocto Liquid and Diocto Syrup Manufactured By PharmaTech, LLC Due to Possible Product Contamination
Rugby ® Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use c ould result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 3, 2017 Category: Food Science Source Type: news

Infectious outbreak in critically ill children leads to recall of contaminated medication
Infection prevention and control experts halted a 24-patient outbreak of Burkholderia cepacia in critically ill children after identifying docusate, a liquid stool softener, as the underlying source of the bacteria. Details of the six-month investigation led to a national recall of all liquid products manufactured by PharmTech. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - February 9, 2017 Category: Science Source Type: news

Infectious outbreak in critically ill children leads to recall of contaminated medication
(Society for Healthcare Epidemiology of America) Infection prevention and control experts at Texas Children's Hospital halted a 24-patient outbreak of Burkholderia cepacia in critically ill children after identifying docusate, a liquid stool softener, as the underlying source of the bacteria. Details of the six-month investigation, published online in Infection Control& Hospital Epidemiology, the journal for the Society for Healthcare Epidemiology of America, led to a national recall of all liquid products manufactured by PharmTech. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - February 9, 2017 Category: Infectious Diseases Source Type: news

Class I Medical Device Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections
Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 3, 2017 Category: Medical Equipment Source Type: news

Stryker ’ s Sage Products invests $3.4m to expand HQ
Stryker (NYSE:SYK) subsidiary Sage Products purchased 27 acres of land in Cary, Ill. for $3.4 million, looking to expand its headquarters in the area, according to a Daily Herald report. Sage makes products for oral care, skin preparation & protection, patient cleaning & hygiene, turning & positioning and heel care. The planned expansion includes an 810,000 square foot addition to the facilities, and is slated to add an additional 350 jobs by 2021, according to the report. Stryker closed its $2.7 billion acquisition of Sage Products in April. The deal for Sage Products, which makes...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Sage Products Stryker Source Type: news

An Unusual case of Burkholderia dolosa Infection in a Cystic Fibrosis Patient but Not His Sister
Irreversible decline in lung function is one of the key contributors to mortality and morbidity in the cystic fibrosis (CF) population [1]. One key determinant of lung health is recurrent respiratory infections with opportunistic pathogens. Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Haemophilus influenzae, non-tuberculous mycobacteria, Staphylococcus aureus, Aspergillus fumigatus, and Burkholderia cepacia complex (BCC) are common opportunistic agents of infections or chronic pulmonary colonizers in the CF population [1]. (Source: Clinical Microbiology Newsletter)
Source: Clinical Microbiology Newsletter - November 19, 2016 Category: Microbiology Authors: Grace Y. Lam, Josette Salgado, Jamil Kanji, James E.A. Zlosnik, Neil E. Brown, Winnie M. Leung Tags: Case Report Source Type: news

In South Jersey, 13 sick with bacterial infection linked to contaminated syringes
Pre-filled syringes produced by a Texas-based medical device manufacturer are linked to 13 new cases of a bacterial infection in New Jersey, where several dozen people have already been affected. The 13 new cases, 10 in Atlantic County and three in Ocean County, come five weeks after Halton City, Texas-based Nurse Assist voluntarily recalled all of its I.V. flush syringes "due to a potential link to Burkholderia cepacia bloodstream infections with the product," according to the FDA. The v oluntary… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 14, 2016 Category: Pharmaceuticals Source Type: news

Nurse Assist Initiates Nationwide Voluntary Recall of All Unexpired Lots of I.V. Flush Syringes
Nurse Assist, Inc. announced today that it is voluntarily recalling all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product.  According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people'vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.' If a patient is having symptoms, contact your health care provider. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 5, 2016 Category: Food Science Source Type: news

USFDA slaps ban on API supplied by India ’s Laxachem
The USFDA has banned products of Laxachem Organics, a maker of active pharmaceutical ingredients, from US markets as part of the effort to arrest the Burkholderia cepacia or the B Cepacia infection (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 20, 2016 Category: Pharmaceuticals Source Type: news

Health Canada recalls Sage Product cleansing cloths
A line of disposable cleansing cloths commonly used in hospitals across the country has been recalled by the company due to possible Burkholderia cepacia contamination. (Source: CBC | Health)
Source: CBC | Health - September 8, 2016 Category: Consumer Health News Tags: News/Canada/Nova Scotia Source Type: news

Burkholderia cepacia: a Complex Problem for More than Cystic Fibrosis Patients
It is always surprising to find that an organism we know only from the clinical laboratory is a “player” in other venues. Therefore, it was with some fascination that we learned that Burkholderia cepacia, long known as a pathogen in cystic fibrosis patients, is also the number one organism isolated from product recalls. We recount the story of this amazing organism, which has a place in th e clinical, agricultural, and pharmaceutical sectors. (Source: Clinical Microbiology Newsletter)
Source: Clinical Microbiology Newsletter - September 3, 2016 Category: Microbiology Authors: Nehemiah J. Landes, Hannah N. Livesay, Fran Schaeffer, Pam Terry, Ernest Trevino, Alice Schauer Weissfeld Source Type: news

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 t...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Hospital Care Recalls Sage Products Stryker Source Type: news

Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination - Second Expansion
Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail and consumer/user levels. The recall is being initiated due to potential product contamination with the bacteria, Burkholderia cepacia. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 22, 2016 Category: Food Science Source Type: news

Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
Cary, IL, Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 17, 2016 Category: Food Science Source Type: news

PharmaTech Recalls All Liquid Products
Florida-based PharmaTech LLC is voluntarily recalling all liquid products dated from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 9, 2016 Category: Pharmaceuticals Source Type: news

More Liquid Products Recalled During B. cepacia Outbreak (FREE)
By the Editors PharmaTec, LLC is recalling all of its liquid products over concerns that they may be contaminated with Burkholderia cepacia, … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - August 9, 2016 Category: Primary Care Source Type: news

PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination
PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 9, 2016 Category: Food Science Source Type: news

Contaminated Comfort Shield Barrier Cream Cloths Recalled Contaminated Comfort Shield Barrier Cream Cloths Recalled
Comfort Shield Barrier Cream Cloths have been recalled by Sage Products because they may be contaminated with Burkholderia cepacia.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 3, 2016 Category: Consumer Health News Tags: Nursing News Alert Source Type: news

Sage Products Issues Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
CARY, Ill., USA, July 29, 2016 /PRNewswire/ -- Sage Products announced today it is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 1, 2016 Category: Food Science Source Type: news

PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination
PharmaTech LLC of Davie, FL, the manufacturer of the Rugby®- branded product, is voluntarily recalling all lots within the expiry of Diocto Liquid, a docusate sodium solution due to a risk of product contamination with Burkholderia cepacia. Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. (Source: Food and Drug Administration)
Source: Food and Drug Administration - July 16, 2016 Category: Food Science Source Type: news

Don't Use Oral Liquid Docusate in Any Patient, CDC WarnsDon't Use Oral Liquid Docusate in Any Patient, CDC Warns
The advice comes as health officials continue to investigate a multistate outbreak of Burkholderia cepacia infections possibly linked to contaminated oral liquid docusate stool softener products. News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 11, 2016 Category: Consumer Health News Tags: Infectious Diseases News Alert Source Type: news

CDC Warns of Multistate Outbreak of Burkholderia cepacia Infection
The CDC and FDA have joined forces with various state and local health departments and health care facilities to investigate a multistate outbreak of Burkholderia cepacia infections. (Source: AAFP News)
Source: AAFP News - June 27, 2016 Category: Primary Care Source Type: news

Baby Wipes Company Nutek Disposables Issues Recall After Possible Contamination
(Source: Healthy Living - The Huffington Post)
Source: Healthy Living - The Huffington Post - October 27, 2014 Category: Consumer Health News Source Type: news

Zicam Extreme Congestion Relief Nasal Gel: Recall—Contamination With Burkholderia Cepacia
Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism. (Source: NCCAM Featured Content)
Source: NCCAM Featured Content - December 19, 2012 Category: Complementary Medicine Authors: NCCAM Source Type: news