FDAClass IIMarch 23, 2022

Jagtome recall: Sterility Concern

JAGTOME RX 49-30-260-035 Material Number: M00573020

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: 27571949 GTIN: 8714729776734

Product
JAGTOME RX 49-30-260-035 Material Number: M00573020
Recalling firm
Boston Scientific Corporation
Quantity
96 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)
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