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Recall Observatory FDA recall evidence

Device product

Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

Z-1565-2020

March 06, 2020

Class II

Product summary

Firm
Cook Inc.
Event
Event 85187
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-1565-2020

Official wording

Reason: The printed expiration dates are incorrect.

Code information: Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

Distribution pattern: The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The printed expiration dates are incorrect.