MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro
FDA device recall Z-2017-2012 · posted 2012-07-16 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FYA
- Quantity affected
- 79,941 units
- Distribution
- Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
- Date initiated
- 2009-09-17
- Date posted
- 2012-07-16
- Date terminated
- 2012-07-19
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 (K091357) | Kimberly-Clark Corp. | 2009-08-10 |