Recall record at a glance
| Official record | Z-0995-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Kimberly-Clark Corporation |
| Report date | Apr 3, 2013 |
| Recall initiation date | Mar 6, 2013 |
| Quantity | Code 68507 - 6420 cases; Code 68509 - 1281 cases |
| Location | Roswell, GA, United States |
Official 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.
Why the product was recalled
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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