ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to pr

FDA device recall Z-0257-2013 · posted 2012-11-07 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Action taken

Kimberly Clark sent an Urgent Voluntary Product Recall letter dated July 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to determine if they have any affected product in their inventory. Any affected product should be quarantined and distribution discontinued. Distributors were also asked to conduct a sub-recall for any affected product further distributed. Customers were asked to complete the attached Distributor Product Recall Response Form and fax to 1-920-225-3522. Upon completion of the response form customers were asked to destroy any affected product. For questions regarding this recall call 770-587-7835.

Root cause

Packaging process control

Status

Terminated

Product code

KKX

Quantity affected

89,856 (28 units per case)

Distribution

Nationwide Distribution

Date initiated

2012-07-05

Date posted

2012-11-07

Date terminated

2013-06-13

Location

Roswell, GA

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