FDA Device

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Hazard

Procedure packs contained a recalled product.

What You Should Do

Remedy

DeRoyal issued their recall notification on 08/12/2022 to the end user level by emailing recall letters to affected consignees. The consignees are asked to identify the affected products and return any affected product and to complete the return form back to DeRoyal.

Products

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Brand
DeRoyal Industries Inc
UPC
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

Units Affected

1306 kits