Recall Z-1402-2017— Metrex Research, LLC.
Class II · Terminated
Class II FDA medical device recall by Metrex Research, LLC., initiated 2017-01-20, terminated 2017-09-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process..
- Recalling firm
- Metrex Research, LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-20
- Terminated
- 2017-09-01
- Firm location
- Romulus, MI, United States
Product description
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.
Reason for recall
Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.