Recall Z-0995-2013 ยท FRG Wrap, Sterilization
Kimberly-Clark Corporation
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.
| Date | Mar 26, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. |
| Root cause | Component design/selection |
| Action | All US distributors and clinics were sent an Urgent: Voluntary Product Recall letter via Federal Express, and the Canadian importer/distributor was also notified with the same letter via Federal Express and e-mail. Distributors were instructed to contact their customers by sending a copy of the letter. The letter identified the affected product and stated the reason for the recall. The recall notification includes a Response Sheet that allows the customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected pr |
| Quantity | Code 68507 - 6420 cases; Code 68509 - 1281 cases |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881471 | KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP Kimberly-Clark Corp., Aug 10, 1988 |