FDAClass IISeptember 7, 2022

DeRoyal Sterile Custom Kits containing ICU Medical recall

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Why was DeRoyal Sterile Custom Kits containing ICU Medical recalled?

Procedure packs contained a recalled product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Recalling firm
DeRoyal Industries Inc
Quantity
1306 kits
Distribution
US Nationwide distribution in the states of OH and TN.
Recall date
September 7, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls