Z-1402-2017Class II

CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface...

Name: Z-1402-2017 CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface...
Creator: Metrex Research, LLC.
Published: 2017-01-20
License: https://open.fda.gov/license/

Metrex Research / initiated 2017-01-20 / Terminated / root cause: packaging

FDA source

Metrex Research, LLC. began a recall of 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... on 2017-01-20. FDA classified it as Class II and gives the reason as "Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1402-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-20
Posted: 2017-03-03
Terminated: 2017-09-01
Recalling firm: Metrex Research
Product: 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.
Product code: LRJ Disinfectant, Medical Devices
Reason for recall: Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 960 cases
Distribution: Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
Product codes and lots: Lot No. 16-2340PA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1402-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1402-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code LRJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)