Class 2 Device Recall StoneBreaker Sterilization Cap

• Date Initiated by Firm: January 31, 2018
• Create Date: May 02, 2018
• Recall Status: Terminated on April 17, 2020
• Recall Number: Z-1594-2018
• Recall Event ID: 79731
• 510(K)Number: K062475
• Product Classification: Lithotriptor, electro-hydraulic - Product Code FFK
• Product: StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department ; 812-339-2235
• Manufacturer Reason for Recall: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
• FDA Determined Cause: Error in labeling
• Action: On March 8, 2018 Cook Medical sent customers notification of an Urgent Medical Device Recall . Customers were instructed to complete the following actions: 1. Examine inventory immediately to determine if you have affected product, and quarantine affected product(s). Immediately cease all distribution and use of these products. 2.Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form. Used devices being returned should be double-bagged, placed inside an outer puncture free package with sufficient cushioning material to prevent movement between the secondary container and the outer package. An itemized list of the components must be placed in the container and the outer package marked Used Medical Device . 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. Immediately report adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Customers with medical questions or concerns can contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
• Quantity in Commerce: 470
• Distribution: US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA
• 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 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 = FFK