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Recall Observatory FDA recall evidence

Device product

9x15" Medium Utility Positioner with Cover

Z-0417-2018

July 26, 2017

Class II

Product summary

Firm
Molnlycke Health Care, Inc
Event
Event 78058
Status
Terminated
Classification
Class II
Quantity
204 units total
Official record key
device-enforcement:Z-0417-2018

Official wording

Reason: Products may not meet specifications due to possible presence of metal shavings.

Code information: Recorder Code 1400239

Distribution pattern: Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    metal shavings
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    may not meet specifications