FDA-Device2017-03-01Class III
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
DeRoyal Industries Inc
Hazard
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.
Sold states
MS & LA
Affected count
849 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2017Don't want to check this manually?
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