Z-1668-2022Class II

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Name: Z-1668-2022 DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Creator: DeRoyal Industries Inc
Published: 2022-08-12
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2022-08-12 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors on 2022-08-12. FDA classified it as Class II and gives the reason as "Procedure packs contained a recalled product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1668-2022
Classification: Class II
Status: Terminated
Initiated: 2022-08-12
Posted: 2022-08-31
Terminated: 2024-09-20
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Product code: LRO General Surgery Tray
Reason for recall: Procedure packs contained a recalled product.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 1306 kits
Distribution: US Nationwide distribution in the states of OH and TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1668-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1668-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-07	2022-08-31

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)