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

FDA device recall Z-1402-2017 · posted 2017-03-03 · Terminated

Recall details

Recalling firm

Metrex Research, LLC.

Reason for recall

Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.

Action taken

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

Status

Terminated

Product code

LRJ

Quantity affected

960 cases

Distribution

Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY

Date initiated

2017-01-20

Date posted

2017-03-03

Date terminated

2017-09-01

Location

Romulus, MI