HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Reported: March 23, 2022 Initiated: December 22, 2021 #Z-0760-2022
Product Description
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 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.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
HYDRATOME RX 44-20MM/450CM Material Number: M00583060. Recalled by Boston Scientific Corporation. Units affected: 254 units.
Why was this product recalled? ▼
Sterility of device is compromised due to a sterile barrier breach
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Moderate. Recall number: Z-0760-2022.
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