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Terminated

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

FDA Recall Z-1668-2022 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2022-08-12
Date Terminated2024-09-20
Product Quantity1306 kits

Reason for Recall

Procedure packs contained a recalled product.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

US Nationwide distribution in the states of OH and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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