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Terminated

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15

FDA Recall Z-1414-2020 · Posted 2020-02-19

Recalling FirmDeroyal Industries, Inc. Lafollette
Recall StatusTerminated
Product CodeLRO
Date Initiated2020-02-04
Date Terminated2021-04-01
Product Quantity2100 units

Reason for Recall

Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Firm Action

DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.

Root Cause

Environmental control

Distribution Pattern

US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

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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