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Recall Observatory FDA recall evidence

Device product

JAGTOME RX 44-20-260-035 Material Number: M00573040

Z-0773-2022

December 22, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 89468
Status
Ongoing
Classification
Class II
Quantity
3578 units
Official record key
device-enforcement:Z-0773-2022

Official wording

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

Code information: Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659

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