Recall Z-2004-2015 ยท LRO General Surgery Tray
Stradis Healthcare, LLC.
Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
| Date | Jul 7, 2015 (initiated Apr 20, 2015) |
| Status | Completed |
| Reason | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 3 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.