Recall Z-0920-2011 ยท FYA Gown, Surgical
Kimberly-Clark Corporation
Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
| Date | Jan 18, 2011 (initiated Dec 23, 2010) |
| Status | Terminated |
| Reason | Product was not properly sterilized. |
| Root cause | Pending |
| Action | Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distrib |
| Quantity | 200 cases (32 units per case) |
| Distribution | Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.