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U.S. Department of Health and Human Services

Class 2 Device Recall Double Pump RF Patient Cassette

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  Class 2 Device Recall Double Pump RF Patient Cassette see related information
Date Initiated by Firm May 10, 2016
Create Date August 30, 2016
Recall Status1 Terminated 3 on September 18, 2017
Recall Number Z-2705-2016
Recall Event ID 74190
510(K)Number K093409  
Product Classification Arthroscope - Product Code HRX
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.
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.
Recalling Firm/
Manufacturer		 Medical Vision Ab
Haestholmsvaegen 32
Nacka Sweden
Manufacturer Reason
for Recall		 Sterility of device may be compromised due to sterile package breakage.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The An Urgent Field Safety Notice: Medical Device Field Safety Corrective Action / Recall letter was sent via certified mail on May 10, 2016. The letter informs customers of the issue and asks them to take the following actions: 1. Locate and quarantine affected unused devices immediately; 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of this action.
Quantity in Commerce 3,295 devices
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = MEDICAL VISION AB
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