KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose an

FDA device recall Z-0995-2013 · posted 2013-03-26 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

FRG

Quantity affected

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 W

Date initiated

2013-03-06

Date posted

2013-03-26

Date terminated

2013-09-16

Location

Roswell, GA

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