HYDRATOME RX 49-20MM/260CM Material Number: M00583000
FDA Recall #Z-0763-2022 — Class II — December 22, 2021
Product Description
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
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
112 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: 27852433 28028722 GTIN: 8714729755159
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated