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Recall Observatory FDA recall evidence

Device product

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Z-1668-2022

August 12, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 90749
Status
Terminated
Classification
Class II
Quantity
1306 kits
Official record key
device-enforcement:Z-1668-2022

Official wording

Reason: Procedure packs contained a recalled product.

Code information: NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627

Distribution pattern: US Nationwide distribution in the states of OH and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Procedure packs contained a recalled product.