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Recall Observatory FDA recall evidence

Device product

Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

Z-1426-2018

February 23, 2017

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 76620
Status
Terminated
Classification
Class II
Quantity
1200 units
Official record key
device-enforcement:Z-1426-2018

Official wording

Reason: The integrity of the sterile packaging is potentially compromised.

Code information: Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185

Distribution pattern: Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging is potentially compromised