DeRoyal Industries Inc recalls DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89…

Recall date

September 10, 2015

Source

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

Recall number

Z-0363-2016

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

Distributed in MO, MA, NC, CT, Kuwait.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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