Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
FDA Recall Z-2705-2016 · Posted None
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Recalling FirmMedical Vision Ab
Recall StatusTerminated
Product CodeHRX
Date Initiated2016-05-10
Date Terminated2017-09-18
Product Quantity3,295 devices
Reason for Recall
Sterility of device may be compromised due to sterile package breakage.
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.
Root Cause
Unknown/Undetermined by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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