FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2705-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-05-10
- Posted
- not on file
- Terminated
- 2017-09-18
- 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 maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of this action.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K093409"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3003647329
- Firm city
- Nacka
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28