Z-0995-2013 Class II Terminated
FDA device recall Z-0995-2013 was initiated by Kimberly-Clark Corporation on March 6, 2013 and is designated Class II. Reason for recall: Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. The recall status is terminated (terminated September 16, 2013). Affected quantity: Code 68507 - 6420 cases; Code 68509 - 1281 cases.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2013
- Initiation Date
- March 6, 2013
- Termination Date
- September 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Code 68507 - 6420 cases; Code 68509 - 1281 cases
Product Description
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.
Reason for Recall
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Distribution Pattern
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.
Code Information
Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX.