DeRoyal Sterile Custom Kits containing ICU Medical… recallZ-1668-2022 · DeRoyal Industries Inc · initiated Aug 12, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Procedure packs contained a recalled product.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-1668-2022
- Status
- Terminated
- Initiated by the company
- Aug 12, 2022
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 1306 kits
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US Nationwide distribution in the states of OH and TN.
Product description
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-6817Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8762Deroyal Industries, Inc. · General surgery tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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