Jagtome recall: Sterility Concern
JAGTOME RX 44-20-450-035 Material Number: M00573050
Why was Jagtome recalled?
Sterility of device is compromised due to a sterile barrier breach
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666
- Product
- JAGTOME RX 44-20-450-035 Material Number: M00573050
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 3578 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
- Recall date
- March 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)