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

FDA device recall Z-0363-2016 · posted 2015-12-02 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

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.

Action taken

DeRoyal issued their recall on 09/10/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete. Hospitals were provided with labels to affix to the kits with the direction to discard the recalled component and notice of destruction forms to be completed and returned.

Root cause

Other

Status

Terminated

Product code

LRO

Quantity affected

836 units

Distribution

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

Date initiated

2015-09-10

Date posted

2015-12-02

Date terminated

2018-06-22

Location

Powell, TN