MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This recall has been terminated (originally issued November 7, 2012).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- July 5, 2012
- Posted
- November 7, 2012
- Terminated
- June 13, 2013
- Recall Number
- Z-0258-2013
- Quantity
- 933 ((30 units per case)
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Distribution
Nationwide Distribution
Lot / Code Info
Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***
Root Cause
Packaging process control
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.