Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2267-2012Class II

CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number...

Metrex Research / initiated 2012-02-06 / Terminated

Metrex Research, LLC. began a recall of CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2267-2012
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Metrex Research
Product
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.
Product code
LRJ Disinfectant, Medical Devices
Reason for recall
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.
FDA root cause
Component change control
Action
Metrex sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Mandatory Recall Response Form was attached for customers to complete and return via fax to 734-947-6725. Contact Customer Care Center at (800) 841-1428 for questions regarding this recall.
Quantity in commerce
17,690 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2267-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2267-2012Class IITerminatedVoluntary: Firm initiated