—#163194

Product

StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020

FDA product code: FFK — Lithotriptor, Electro-Hydraulic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K062475
Affected lot / code info: All Lots

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2018-01-31
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.