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Recall Observatory FDA recall evidence

Device product

Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

Z-1817-2017

October 20, 2016

Class II

Product summary

Firm
Micromedics, Inc.
Event
Event 75890
Status
Terminated
Classification
Class II
Quantity
273 units
Official record key
device-enforcement:Z-1817-2017

Official wording

Reason: The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.

Code information: Lot Number: 163010 Expiration date: June 2021

Distribution pattern: AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch, If the channels are present, the package integrity may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package integrity may be compromised which may affect sterility