Z-1594-2018Class II

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

Name: Z-1594-2018 StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Creator: Cook Inc.
Published: 2018-01-31
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-01-31 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020 on 2018-01-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1594-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-31
Posted: 2018-05-02
Terminated: 2020-04-17
Recalling firm: Cook Incorporated
Product: StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Product code: FFK Lithotriptor, Electro-Hydraulic
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.
Root cause tag: labeling and UDI
FDA root 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 ([email protected]). 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: [email protected]. 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
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1594-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1590-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1591-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1592-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1593-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1594-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1595-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1596-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02

Product code FFK

K062475Class IILma Stonebreaker Device; Probe Size 1.0Mm, 1.6Mm, 2.0MmThe Laryngeal Mask Co., Ltd. / cleared 2007-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)