FDAClass IIMarch 23, 2022

Jagtome recall: Sterility Concern

JAGTOME RX 39-20-260-025 Material Number: M00573080

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: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642

Product
JAGTOME RX 39-20-260-025 Material Number: M00573080
Recalling firm
Boston Scientific Corporation
Quantity
4487 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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