Windstone Medical, Inc.
Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK
| Date | Apr 22, 2003 (initiated Mar 25, 2003) |
| Status | Terminated |
| Reason | Product has latex free symbol on package, yet contains latex components. |
| Root cause | Other |
| Action | On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm. |
| Quantity | 8 |
| Distribution | The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA. |
| FDA record | Open on fda.gov |