Class 2 Device Recall

• Date Initiated by Firm: March 25, 2003
• Date Posted: April 22, 2003
• Recall Status: Terminated on September 09, 2003
• Recall Number: Z-0753-03
• Recall Event ID: 25830
• 510(K)Number: K902475 K923233 K923231
• Product: 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
• Code Information: Catalog number 002117-000 Lot numbers 000006595, 000006895
• Recalling Firm/ Manufacturer: Windstone Medical, Inc.; 1602 4th Ave North; Billings MT 59101
• For Additional Information Contact: Troy Berquist; 406-259-6387
• Manufacturer Reason for Recall: Product has latex free symbol on package, yet contains latex components.
• FDA Determined 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 in Commerce: 8
• Distribution: The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = and Original Applicant = CARDIO-MED-ASSOCIATES, INC.; 510(K)s with Product Code = and Original Applicant = CARDIO-PAK