CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAIN

FDA device recall Z-1236-2023 · posted 2023-03-09 · Open, Classified

Recall details

Recalling firm

Carefusion 2200 Inc

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.

Action taken

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.

Root cause

Packaging change control

Status

Open, Classified

Product code

KCT

Quantity affected

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, Malaysi

Date initiated

2023-01-30

Date posted

2023-03-09

Location

Vernon Hills, IL

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