FDAFDA · Food and drugs·Recall number Z-0763-2022
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Published March 23, 2022 · Recall initiated: December 22, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of device is compromised due to a sterile barrier breach
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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.
- Lot
- Lot Numbers: 27852433 28028722 GTIN: 8714729755159
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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