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Recall Observatory FDA recall evidence

Device product

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Z-0762-2022

December 22, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 89468
Status
Ongoing
Classification
Class II
Quantity
251 units
Official record key
device-enforcement:Z-0762-2022

Official wording

Reason: Sterility of device is compromised due to a sterile barrier breach

Code information: Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised due to a sterile barrier