Recall Z-0366-2017 ยท LRO General Surgery Tray
Covidien LLC
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, s
| Date | Sep 29, 2016 |
| Status | Terminated |
| Reason | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity |
| Root cause | Process control |
| Action | Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888 |
| Quantity | 4950 units |
| Distribution | Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.