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Terminated

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

FDA Recall Z-1247-2017 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-01-25
Date Terminated2022-01-13
Product Quantity849 units

Reason for Recall

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

Firm Action

DeRoyal issued their recall on 01/25/17 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors and hospitals were instructed to return the tracecarts to DeRoyal.

Root Cause

Other

Distribution Pattern

MS & LA

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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