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