FDA-Device2013-04-03Class II
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Kimberly-Clark Corporation
Hazard
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Sold states
Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.
Affected count
Code 68507 - 6420 cases; Code 68509 - 1281 cases
Manufactured in
1400 Holcomb Bridge Rd, Roswell, GA, United States
Products
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2013Don't want to check this manually?
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