Basic Pack - contains Devon Light Glove Used during surgery

FDA device recall Z-1993-2015 · posted 2015-07-07 · Completed

Recall details

Recalling firm

Stradis Healthcare, LLC.

Reason for recall

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.

Root cause

Nonconforming Material/Component

Status

Completed

Product code

LRO

Quantity affected

6

Distribution

Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

Date initiated

2015-04-20

Date posted

2015-07-07

Location

Lawrenceville, GA