Home / Recalls / Medical Vision Ab / Z-2705-2016

Z-2705-2016 Class II Terminated

Recalled by Medical Vision Ab — Nacka, N/A

Recall Details

Product Type: Devices
Report Date: September 7, 2016
Initiation Date: May 10, 2016
Termination Date: September 18, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,295 devices

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.

Distribution Pattern

Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.

Code Information

All lot numbers of Double Pump RF Patient Cassettes delivered to the US, Batch numbers: 13I03, 14A01, 14A06, 14A09, 14A10, 14B03, 14B09, 14C06, 14C10, 14D07, 14D11, 14E06, 14E10, 14F01, 14F02, 14F03, 14F04, 14F10, 14F11, 14G07, 14H02, 14H04, 14H08, 14H09, 14J01, 14J02, and 14J03.