Recall Z-2643-2020 ยท EZD Catheter, Straight
Wellspect HealthCare (Division of DENTSPLY IH AB)
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
| Date | Jun 17, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT Astra Tech, Inc., Oct 31, 2012 |