Recall Z-2619-2023— R A Medical Services

Name: FDA recall Z-2619-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-23

Class II · Ongoing

Class II FDA medical device recall by R A Medical Services, initiated 2023-08-23. It names one FDA 510(k) clearance: K160950. Product: MINISCAV (tm) Vacuum Pump. Reason: Inadequate documentation of acceptance activity.

Recalling firm: R A Medical Services
Classification: Class II
Status: Ongoing
Initiated: 2023-08-23
Firm location: Keighley, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K160950 — MINISCAVSedation Systems, LLC·cleared 2017-05-05

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

MINISCAV (tm) Vacuum Pump

Reason for recall

Inadequate documentation of acceptance activity

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