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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62864
Product Type Devices
Status Terminated
Recalling Firm Metrex Research, LLC.
City Romulus
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas. CaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345. EnviroCide Lot # 10-2331. Backscratchers Cavicide lot # 10-1342. MaxiSpray Plus lot # 10-2328A and 10-1343. pdCARE Surface Disinfectant lot # 10-2331 and 10-2345. Z3 Surface Disinfectant lot # 10-2328. Class II Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort. 17,690 units Z-2267-2012