Device Recall ULTRA Fabric Reinforced surgical Gown XLarge Sterile 의 리콜

Recall

63598

Class 2

Z-0257-2013

2012-07-05

2012-11-07

Terminated

United States

2013-06-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114310

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

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.