Skip to content
Recall Observatory FDA recall evidence

Device product

StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608

Z-1596-2018

January 31, 2018

Class II

Product summary

Firm
Cook Inc.
Event
Event 79731
Status
Terminated
Classification
Class II
Quantity
12,556
Official record key
device-enforcement:Z-1596-2018

Official wording

Reason: 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.

Code information: All Lots

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.