Z-0771-2022 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
March 23, 2022
Initiation Date
December 22, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
98 units

Product Description

JAGTOME RX 39-30-260-025 Material Number: M00573100

Reason for Recall

Sterility of device is compromised due to a sterile barrier breach

Distribution Pattern

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.

Code Information

Lot Numbers: 27857328 GTIN: 8714729776529