Recall Z-1017-2020 ยท FYA Gown, Surgical
Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
| Date | Jan 24, 2020 (initiated Jan 11, 2020) |
| Status | Terminated |
| Reason | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Root cause | Vendor change control |
| Action | A letter dated 1/11/20 informed customers that: Cardinal Health has become aware of a quality issue related to the manufacture of certain AAMI Level 3 surgical gowns. We have initiated an investigation, placed a hold on product inventory, and are working with the U.S. Food and Drug Administration (FDA) to address this issue. This inventory hold affects certain lots of bulk non-sterile and single-sterile Cardinal Health" surgical gowns and Presource procedure packs that include these surgical gowns. Your local sales representative will provide specific details. Cardinal Health intends to init |
| Quantity | 7,659,634 total units |
| Distribution | Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N Cardinal Health 200, Inc., Jun 5, 2006 |