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Recall Observatory FDA recall evidence

Device product

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

Z-0497-2018

August 24, 2017

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 78943
Status
Terminated
Classification
Class II
Quantity
77
Official record key
device-enforcement:Z-0497-2018

Official wording

Reason: In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

Code information: Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850

Distribution pattern: Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.