The FDA and Cary, Ill.-based Sage Products June 23 announced a voluntary recall of lots of Comfort Shield Perineal Care washcloths shipped between Feb. 10 and May 19 to hospitals, medical centers and long-term care facilities in the U.S. and Canada. Some of the devices may be contaminated with Burkholderia cepacia, which can cause bacterial sepsis in people with weak immune systems, cystic fibrosis (CF), hospitalized patients and certain other patient groups, the company said. The recall was initiated after Sage received a complaint from Canada of an "off odor" in one lot of the products. There have been no reports of patient injury, the company said. FDA (http://www.fda.gov/oc/po/firmrecalls/sage06_06.html.)
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Matrix Surgical’s OmniPore Implants Cleared for Marketing
The company expects to launch additional variants in early 2019.
AbbVie, Novartis Reach Deal on Humira Biosimilar
AbbVie reported Humira sales of $18.4 billion in 2017.