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Terminated

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

FDA Recall Z-2499-2021 · Posted 2021-09-29

Recalling FirmDeroyal Industries, Inc. Lafollette
Recall StatusTerminated
Product CodeLRO
Date Initiated2021-09-02
Date Terminated2023-12-18
Product Quantity2880 units

Reason for Recall

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

Firm Action

DeRoyal issued their recall on 09/03/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution in Florida and South Carolina.

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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