Double Pump RF Patient Cassette recall: Sterility Concern
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and…
Why was Double Pump RF Patient Cassette recalled?
Sterility of device may be compromised due to sterile package breakage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and…
- Recalling firm
- Medical Vision Ab
- 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.
- Recall date
- September 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)