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Recall Observatory FDA recall evidence

Device product

Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053

Z-1566-2020

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-1566-2020

Official wording

Reason: The printed expiration dates are incorrect.

Code information: Lot Number 10235662; UDI: (01)00827002480537(17)562310(10)10235662

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.