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Cook Inc. recalls StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
Recalled May 9, 2018 · FDA recall Z-1595-2018 · Cook
Hazard
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 Class II
Units
38,542
Sold at
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
Description
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.
Product
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →