Molndal, N/A, Sweden
Wellspect HealthCare (Division of DENTSPLY IH AB) recalls
1 recall recorded since 2018, most recently on 17 June 2020. 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
- 17 June 2020
- Terminated
- 9 April 2021
- Reason
- Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
- Distribution
- AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2644-2020, Z-2645-2020, Z-2643-2020
- LoFric Origo, Tiemann, 16in, FR12 urinary catheters
- LoFric Origo, Tiemann, 16in, FR14 urinary catheters
- LoFric Origo, Nelaton, 16in, FR10 urinary catheters
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.