Z-1595-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- January 31, 2018
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,542
Product Description
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
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.
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
Code Information
All Lots