Class 2 Device Recall CaviCide

• Date Initiated by Firm: February 06, 2012
• Date Posted: August 24, 2012
• Recall Status: Terminated on August 24, 2012
• Recall Number: Z-2267-2012
• Recall Event ID: 62864
• 510(K)Number: K951123
• Product Classification: Disinfectant, medical devices - Product Code LRJ
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Metrex Research, LLC.; 28210 Wick Rd; Romulus MI 48174-2639
• For Additional Information Contact: 734-946-7800
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LRJ and Original Applicant = MICRO-ASEPTIC PRODUCTS, INC.