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.
This recall has been terminated (originally issued March 26, 2013).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- March 6, 2013
- Posted
- March 26, 2013
- Terminated
- September 16, 2013
- Recall Number
- Z-0995-2013
- Quantity
- Code 68507 - 6420 cases; Code 68509 - 1281 cases
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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 product. The customer is instructed to immediately cease further distribution of the product, physically quarantine and destroy the product, and fax the completed Response Sheet to the Kimberly-Clark Recall Coordinator.