Atlas FDA

CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private

FDA device recall Z-2267-2012 · posted 2012-08-24 · Terminated

Recall details

Recalling firm
Metrex Research, LLC.
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.
Action taken
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.
Root cause
Component change control
Status
Terminated
Product code
LRJ
Quantity affected
17,690 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
Date initiated
2012-02-06
Date posted
2012-08-24
Date terminated
2012-08-24
Location
Romulus, MI

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Related 510(k) clearances

RecordFirmDate
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER (K951123)Micro-Aseptic Products, Inc.1995-04-25