Aurora, Canada
Prollenium Medical Technologies Inc. recalls
1 recall recorded since 2018, most recently on 15 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 November 2018
- Terminated
- 22 March 2024
- Reason
- Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
- Distribution
- US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1146-2020
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.