Import Alert 79-01

"Detention Without Physical Examination Plastic Bandages And Cotton Pads Due To Microbiological Contamination"

Microbiological analysis by FDA's Winchester Engineering and Analytical Center of various plastic bandages and cotton pads revealed that they were contaminated with various viable microorganisms using the U.S.P. Sterility Test Method.

Compliance Policy Guide 300.400 (7124.01) addresses contamination of devices labeled as sterile. It indicates that non sterile devices should be given top priority because of the seriousness of the hazard posed by microbial contamination of sterile products. Products such as these are used over open wounds, non-sterile bandages *** and cotton pads *** have the potential to cause serious infections.

CDRH has also indicated that given the intended use of these products, even if they may not be labeled as sterile, is cause for concern in that they may cause serious infection in some individuals due to the microbial contamination found on them.

Districts may detain, without physical examination, products from the manufacturers identified in the attachmnet for this import alert.

Increased surveillance of similar products from other manufacturers appears warranted.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

Plastic Bandages and Cotton Pads

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since it consists in whole or in part of a filthy, putrid, or decomposed substance namely potentially infectious microorganisms. [Section 501(a)(1)]."

OASIS charge code - STERILITY

Or

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its purity and quality fall balls below that which it is represented to possess [Section 501(c)]."

OASIS charge code - DV QUALITY

In addition,

"The article appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual. [Sections 502(a), 201(n)].

OASIS charge code - LBLG ADVER