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Recall Observatory FDA recall evidence

Device product

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

Z-1425-2018

February 23, 2017

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 76620
Status
Terminated
Classification
Class II
Quantity
14,200 units
Official record key
device-enforcement:Z-1425-2018

Official wording

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

Code information: Product Code: a.) TJM3513 / LOT 0000836582, 0000838949, 0000843968, 0000849685, 0000852933; b.) TJM4008 / LOT 0000841349, 0000841348, 0000843961, 0000849132, 0000852123, 0000853877; c.) TJM4011 / LOT 0000836575, 0000838950, 0000840195, 0000843075, 0000843076, 0000846708, 0000852932, 0000853878, 0000854861, 0000854983; d.) TJM6008 / LOT 0000842725, 0000853971; e.) TJM6011 / LOT 0000843077, 0000849713, 0000854659

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