CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
FDA Recall Z-1402-2017 · Posted 2017-03-03
Recalling FirmMetrex Research, LLC.
Recall StatusTerminated
Product CodeLRJ
Date Initiated2017-01-20
Date Terminated2017-09-01
Product Quantity960 cases
Reason for Recall
Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.
Firm Action
Metrex sent an Urgent Medical Device Recall letter dated January 20, 2017, to all affected customers to inform them that Metrex is recalling one lot of CaviWipes Extra Large because they may have been contaminated during the packaging process. Customers were informed that while handling sealed containers, a production worker sustained a minor finger cut which may have come in contact with the exterior surface of the container. Customers were instructed to contact Metrex Customer care at (800) 537-7123 to receive a RMA number. The RMA will allow for a quick return and replacement or credit. Customers were instructed to identify any customers that may have been shipped the affected product and contact their customers using the customer notification letter that Metrex issued. Metrex requests that those customers contact Metrex Customer Care at (800) 537-7123 and complete the attached acknowledgement form.
For questions regarding this recall call 734-947-6700.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.