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U.S. Department of Health and Human Services

Class 2 Device Recall StoneBreaker Pneumatic Lithotripter

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  Class 2 Device Recall StoneBreaker Pneumatic Lithotripter see related information
Date Initiated by Firm January 31, 2018
Create Date May 02, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1590-2018
Recall Event ID 79731
510(K)Number K062475  
Product Classification Lithotriptor, electro-hydraulic - Product Code FFK
Product StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Code Information All Lots
Recalling Firm/
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
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 2
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 751
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 and Original Applicant = THE LARYNGEAL MASK CO.,LTD.