Z-0763-2022 Class II Ongoing
FDA device recall Z-0763-2022 was initiated by Boston Scientific Corporation on December 22, 2021 and is designated Class II. Reason for recall: Sterility of device is compromised due to a sterile barrier breach The recall status is ongoing. Affected quantity: 112 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- December 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 units
Product Description
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Distribution Pattern
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