Recall Z-1146-2020— Prollenium Medical Technologies Inc.
Class II · Terminated
Class II FDA medical device recall by Prollenium Medical Technologies Inc., initiated 2018-11-15, terminated 2024-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Revanesse Versa, PN40081. Reason: Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months..
- Recalling firm
- Prollenium Medical Technologies Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-15
- Terminated
- 2024-03-22
- Firm location
- Aurora, Canada
Product description
Revanesse Versa, PN40081
Reason for recall
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Data sourced from openFDA. This site is unofficial and independent of the FDA.