Recall Z-2645-2020— Wellspect HealthCare (Division of DENTSPLY IH AB)

Name: FDA recall Z-2645-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-17

Class II · Terminated

Class II FDA medical device recall by Wellspect HealthCare (Division of DENTSPLY IH AB), initiated 2020-06-17, terminated 2021-04-09. It names one FDA 510(k) clearance: K122078. Product: LoFric Origo, Tiemann, 16in, FR14 urinary catheters. Reason: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip..

Recalling firm: Wellspect HealthCare (Division of DENTSPLY IH AB)
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Terminated: 2021-04-09
Firm location: Molndal, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K122078 — LOFRIC PRIMO, LOFRIC HYDRO-KITAstra Tech, Inc.·cleared 2012-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.