Recall Z-2705-2016— Medical Vision Ab

Name: FDA recall Z-2705-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-10

Class II · Terminated

Class II FDA medical device recall by Medical Vision Ab, initiated 2016-05-10, terminated 2017-09-18. It names one FDA 510(k) clearance: K093409. Product: Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.. Reason: Sterility of device may be compromised due to sterile package breakage..

Recalling firm: Medical Vision Ab
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Terminated: 2017-09-18
Firm location: Nacka, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K093409 — POWERPUMP ARTHROSCOPY SYSTEMMedical Vision AB·cleared 2010-02-24

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

Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.

Reason for recall

Sterility of device may be compromised due to sterile package breakage.

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