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Recall Observatory FDA recall evidence

Device product

DREAMTOME 44-30MM/260CM Material Number: M00584050

Z-0753-2022

December 22, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 89468
Status
Ongoing
Classification
Class II
Quantity
12067 units
Official record key
device-enforcement:Z-0753-2022

Official wording

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

Code information: Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271

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