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U.S. Department of Health and Human Services

Class 2 Device Recall V. Mueller Genesis

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  Class 2 Device Recall V. Mueller Genesis see related information
Date Initiated by Firm January 30, 2023
Date Posted March 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-1236-2023
Recall Event ID 91572
510(K)Number K142529  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product 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 3" PERF BOTTOM BLUE;
7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD;
8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN;
9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE;
10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED;
11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK;
12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE;
13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD;
14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN;
15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE;
16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED;
17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK;
18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE;
19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD;
20. CD5-61B-GREEN, GENESIS LG NARROW 6" PERF BOTTOM GREEN;
21. CD5-61B-PURPLE, GENESIS LG NARROW 6" PERF BOTTOM PURPLE;
22. CD5-61B-RED, GENESIS LG NARROW 6" PERF BOTTOM RED;
23. CD5-61C-BLACK, GENESIS LG NARROW 6" SOLID BOTTOM BLACK
24. CD5-61C-BLUE, GENESIS LG NARROW 6" SOLID BOTTOM BLUE;
25. CD5-61C-GOLD, GENESIS LG NARROW 6" SOLID BOTTOM GOLD;
26. CD5-61C-GREEN, GENESIS LG NARROW 6" SOLID BOTTOM GREEN;
27. CD5-61C-PURPLE, GENESIS LG NARROW 6" SOLID BOTTOM PURPLE;
28. CD5-61C-RED, GENESIS LG NARROW 6" SOLID BOTTOM RED.
Code Information All lot numbers are involved. UDI/DI: 1. CD5-3B - 10885403019548; 2. CD5-3C - 10885403019555; 3. CD5-61B - 10885403019579; 4. CD5-61C - 10885403019586; 5. CD5-3B-BLACK - 10885403197970; 6. CD5-3B-BLUE - 10885403197949; 7. CD5-3B-GOLD - 10885403197925; 8. CD5-3B-GREEN - 10885403197956; 9. CD5-3B-PURPLE - 10885403197932; 10. CD5-3B-RED - 10885403197963; 11. CD5-3C-BLACK - 10885403196515; 12. CD5-3C-BLUE - 10885403196485; 13. CD5-3C-GOLD - 10885403196461; 14. CD5-3C-GREEN - 10885403196492; 15. CD5-3C-PURPLE - 10885403196478; 16. CD5-3C-RED - 10885403198700; 17. CD5-61B-BLACK - 10885403198038; 18. CD5-61B-BLUE - 10885403198007; 19. CD5-61B-GOLD - 10885403197987; 20. CD5-61B-GREEN - 10885403198014; 21. CD5-61B-PURPLE - 10885403197994; 22. CD5-61B-RED - 10885403198021; 23. CD5-61C-BLACK - 10885403196577; 24. CD5-61C-BLUE - 10885403196546; 25. CD5-61C-GOLD - 10885403196522; 26. CD5-61C-GREEN - 10885403196553; 27. CD5-61C-PURPLE - 10885403196539; 28. CD5-61C-RED - 10885403196560.
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Mr. Troy Kirkpatrick
858-617-2361
Manufacturer Reason
for Recall		 Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
FDA Determined
Cause 2		 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 can have them disposed of according to their local facility's process; (2) Share the notification with all users of the affected product within their facility network to ensure they are also aware of the recall; (3) If the product was purchased from a distributor, the consignee is to contact the distributor directly for further instructions and credit resolution; (4) Complete the attached Customer Response Form and return it to the BD contact noted on the form. The letter also informs the consignee they will no longer manufacture or distribute the Genesis Reusable Rigid Sterilization Containers (CD5 Series only). The distributor letters were similar except they were requested to identify their customers who purchased the affected product and provide a copy of the customer letter to them. The distributors were to return the Distributor Response Form to the recalling firm acknowledging receipt and that they have read and understand the recall notice.
Quantity in Commerce 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, United Kingdom, United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = CareFusion 2200 Inc
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