Recall Z-2643-2020
Wellspect HealthCare (Division of DENTSPLY IH AB) · initiated June 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Codes / lots: Lot # 447123
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.
FDA-determined cause: Equipment maintenance
Action taken
Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.
Details
- Recall number
- Z-2643-2020
- Initiated
- June 17, 2020
- Terminated
- April 9, 2021
- Product code
- EZD – Catheter, Straight
- 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
- Recalling firm
- Wellspect HealthCare (Division of DENTSPLY IH AB), Molndal
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2644-2020 Class II | LoFric Origo, Tiemann, 16in, FR12 urinary cathetersWellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential… | 06/17/2020Terminated |
| Z-2645-2020 Class II | LoFric Origo, Tiemann, 16in, FR14 urinary cathetersWellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential… | 06/17/2020Terminated |