DeRoyal Heart Tracecart REF recalled over sterility concerns

Recall date

January 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1247-2017

FDA classification

Class III

Brand / firm

DeRoyal Industries Inc

Sold / distributed

MS & LA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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