Z-2705-2016 Class II Terminated
FDA device recall Z-2705-2016 was initiated by Medical Vision Ab on May 10, 2016 and is designated Class II. Reason for recall: Sterility of device may be compromised due to sterile package breakage. The recall status is terminated (terminated September 18, 2017). Affected quantity: 3,295 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2016
- Initiation Date
- May 10, 2016
- Termination Date
- September 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,295 devices
Product Description
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
Reason for Recall
Sterility of device may be compromised due to sterile package breakage.
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.
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.