LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Reported: July 29, 2020 Initiated: June 17, 2020 #Z-2645-2020
Product Description
LoFric Origo, Tiemann, 16in, FR14 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.
Details
- Recalling Firm
- Wellspect HealthCare (Division of DENTSPLY IH AB)
- Units Affected
- N/A
- 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
- Location
- Molndal, N/A
Frequently Asked Questions
What product was recalled? ▼
LoFric Origo, Tiemann, 16in, FR14 urinary catheters. Recalled by Wellspect HealthCare (Division of DENTSPLY IH AB). Units affected: N/A.
Why was this product recalled? ▼
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2645-2020.
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