Recall Z-0258-2013 ยท FYA Gown, Surgical
Kimberly-Clark Corporation
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.
| Date | Nov 7, 2012 (initiated Jul 5, 2012) |
| Status | Terminated |
| Reason | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. |
| Root cause | Packaging process control |
| Action | 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 completi |
| Quantity | 933 ((30 units per case) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103406 | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS Kimberly-Clark Corp., Dec 23, 2010 |