Z-2643-2020 Class II Terminated
FDA device recall Z-2643-2020 was initiated by Wellspect HealthCare (Division of DENTSPLY IH AB) on June 17, 2020 and is designated Class II. Reason for recall: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip. The recall status is terminated (terminated April 9, 2021). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 17, 2020
- Termination Date
- April 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Reason for Recall
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
Distribution Pattern
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
Code Information
Lot # 447123