Z-2705-2016Class II

Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and...

Name: Z-2705-2016 Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and...
Creator: Medical Vision Ab
Published: 2016-05-10
License: https://open.fda.gov/license/

Medical Vision AB / initiated 2016-05-10 / Terminated / root cause: packaging

FDA source

Medical Vision Ab began a recall of Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and... on 2016-05-10. FDA classified it as Class II and gives the reason as "Sterility of device may be compromised due to sterile package breakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2705-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Posted: 2016-08-30
Terminated: 2017-09-18
Recalling firm: Medical Vision AB
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.
Product code: HRX Arthroscope
Reason for recall: Sterility of device may be compromised due to sterile package breakage.
Root cause tag: packaging
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2705-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2705-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code HRX

K093409Class IIPowerpump Arthroscopy SystemMedical Vision AB / cleared 2010-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)