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Recall Observatory FDA recall evidence

Device product

ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

Z-1423-2018

February 23, 2017

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 76620
Status
Terminated
Classification
Class II
Quantity
a.) 13,010 units b.) 2116 units
Official record key
device-enforcement:Z-1423-2018

Official wording

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

Code information: Product Code: a.) TIN3015/ LOT 0000836578, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849715, 0000850938, 0000852076, 0000854859; Product Code: b.) TIN3018/ LOT 0000836574, 0000841212, 0000852078

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