ClearanceBrief
Recall Z-2267-2012 ยท LRJ Disinfectant, Medical Devices

Metrex Research, LLC.

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 disinfe

DateAug 24, 2012 (initiated Feb 6, 2012)
StatusTerminated
ReasonMetrex 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.
Root causeComponent change control
ActionMetrex 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.
Quantity17,690 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K951123CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
Micro-Aseptic Products, Inc., Apr 25, 1995