HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 254 units of the HYDRATOME RX 44-20MM/450CM device due to a sterile barrier breach that compromises the sterility of the device. The affected units are from Lot Numbers Batch 27442309 and 28020415, identified by GTIN 8714729755210. These devices were distributed worldwide, including throughout the United States and in countries including Australia, Canada, China, France, Germany, Japan, and many others.
The recall notice does not specify a remedy or recommended course of action for consumers who may have been affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Sterility of device is compromised due to a sterile barrier breach
Reason for recall: Sterility of device is compromised due to a sterile barrier breach 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 Quantity: 254 units Lot/code info: Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.