Recall Z-2018-2012 ยท FYA Gown, Surgical
Kimberly-Clark Corporation
MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
| Date | Jul 16, 2012 (initiated Sep 17, 2009) |
| Status | Terminated |
| Reason | Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. |
| Root cause | Process control |
| Action | Kimberly Clark sent an Urgent Medical Device Recall letter dated September 17, 2009. to all affected consignees. The Recall notification of the expanded recall was sent to consignees on November 17, 2009. Customers were instructed to destroy all affected product remaining in their inventory. For questions regarding this recall call 770-587-7400. |
| Distribution | Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091357 | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 Kimberly-Clark Corp., Aug 10, 2009 |