Home / Recalls / Wellspect HealthCare (Division of DENTSPLY IH AB) / Z-2644-2020

Z-2644-2020 Class II Terminated

Recalled by Wellspect HealthCare (Division of DENTSPLY IH AB) — Molndal, 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, Tiemann, 16in, FR12 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 catheters 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 # 450422