Recall Z-2705-2016 ยท HRX Arthroscope
Medical Vision Ab
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
| Date | May 10, 2016 |
| Status | Terminated |
| Reason | Sterility of device may be compromised due to sterile package breakage. |
| Root cause | 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 m |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093409 | POWERPUMP ARTHROSCOPY SYSTEM Medical Vision AB, Feb 24, 2010 |