INTELLIFLO DRESSING 의 리콜

Recall

58247

Class 2

Z-2326-2012

2010-08-11

2012-09-06

Terminated

United States

2012-09-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98803

This recall has been initiated due to confirmation that the polar dressing, knee/mu/shldr intelli-flo-breg does not meet the required thickness as specified. the dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". this change in thickness makes the dressing thinner, less durable and subject to tearing. the product is mislabeled.

The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings. If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.