Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, L

FDA device recall Z-1837-2015 · posted 2015-06-25 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes

Action taken

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 4/27/2015 to their customers (i.e., end-user level, its direct accounts and hospitals) via overnight on 04/27/2015. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: a. send Recall Instructions and a listing of their accounts who were shipped affected product (also included were labels, Training forms, Record of Destruction Forms) b. notify Distributors and Hospitals with a list of products shipped to their account with instructions to place any remaining inventory in quarantine. c. document the lots/quantities labeled at their accounts and complete and return this information on the "Affected Product Listing" to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com even if your distributor no longer has any inventory. d. conduct training at the hospitals and this training will be documented on the Recall Training form. e. leave Record of Destruction Forms at the hospital for completion/return to DeRoyal as products are discarded/destroyed. If you have questions or need assistance with the recall, please contact me at 865-362-6465 or tmarsee @deroyal.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

235,785 units

Distribution

Worldwide Distribution: US (nationwide) and country of Guatemala.

Date initiated

2015-04-27

Date posted

2015-06-25

Date terminated

2015-12-29

Location

Powell, TN