Recall Z-0363-2016— DeRoyal Industries Inc

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2015-09-10, terminated 2018-06-22. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02. Reason: These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch..

Recalling firm

DeRoyal Industries Inc

Classification

Class II

Status

Terminated

Initiated

2015-09-10

Terminated

2018-06-22

Firm location

Powell, TN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.