JAGTOME RX 39-20-260-025 Material Number: M00573080
FDA Recall #Z-0768-2022 — Class II — December 22, 2021
Product Description
JAGTOME RX 39-20-260-025 Material Number: M00573080
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Lot Numbers: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated