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Recall Observatory FDA recall evidence

Device 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.

Z-2705-2016

May 10, 2016

Class II

Product summary

Firm
Medical Vision Ab
Event
Event 74190
Status
Terminated
Classification
Class II
Quantity
3,295 devices
Official record key
device-enforcement:Z-2705-2016

Official wording

Reason: Sterility of device may be compromised due to sterile package breakage.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of device may be compromised due to sterile package breakage.