DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot

FDA device recall Z-0241-2016 · posted 2015-11-06 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

Action taken

DeRoyal initiated their recall on 08/31/2015 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 and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. Hospitals were provided with labels to affix to the kits with direction to discard the recalled component and notice of destruction forms to be completed and returned.

Root cause

Other

Status

Terminated

Product code

LRO

Distribution

SC, FL, OH, NJ, OK, MN, AR

Date initiated

2015-08-31

Date posted

2015-11-06

Date terminated

2016-04-12

Location

Powell, TN