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Recall Observatory FDA recall evidence

Device product

Pilling COOLEY SUMP-SUCTION TUBE, REF 351547

Z-0846-2019

January 07, 2019

Class II

Product summary

Firm
Teleflex Medical
Event
Event 81918
Status
Terminated
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-0846-2019

Official wording

Reason: The internal tip is missing from the device, causing the device to not function as intended.

Code information: Lot/Batch Numbers: A8, C8, I7

Distribution pattern: TX, NY, DC and Philippines

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The internal tip is missing from the device, causing the device to not function as intended.