Recall Z-1402-2017 ยท LRJ Disinfectant, Medical Devices
Metrex Research, LLC.
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.
| Date | Mar 3, 2017 (initiated Jan 20, 2017) |
| Status | Terminated |
| Reason | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. |
| 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. |
| Quantity | 960 cases |
| Distribution | Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.