HYDRATOME RX 44-20MM/450CM Material Number: M00583060
FDA Recall #Z-0760-2022 — Class II — December 22, 2021
Product Description
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
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
254 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: Batch 27442309 28020415 GTIN: 8714729755210
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated