Recall Z-1236-2023 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Carefusion 2200 Inc
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW
| Date | Mar 9, 2023 (initiated Jan 30, 2023) |
| Status | Open, Classified |
| Reason | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. |
| Root cause | Packaging change control |
| Action | The recalling firm issued letters to customers and a separate letter to distributors dated 1/30/2023 via email and FedEx. The customer letters described the problem, potential clinical impact, provided product identification including photographs, and provided actions the consignees are to take. Instructions included: (1) Discontinue use of the affected product. Check all inventory locations within their institution for the affected product and immediately destroy all remaining product in their possession. A list of the components and their material makeup are provided so the consignee ca |
| Quantity | 5,952 devices |
| Distribution | Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142529 | Genesis Reusable Rigid Container System Carefusion 2200, Inc., Jan 8, 2015 |