|
Class 2 Device Recall Medtronic |
|
Date Initiated by Firm |
April 16, 2015 |
Date Posted |
July 20, 2015 |
Recall Status1 |
Terminated 3 on June 28, 2017 |
Recall Number |
Z-2108-2015 |
Recall Event ID |
71113 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
Product |
Mini-Kits, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31141578 K-1840-S OR Mini Kit 31141586 K-1660-S OR Mini Kit 31141602 K-1630-S OR Mini Kit 31141610 K-1615-S OR Mini Kit 31141628 K-1614-S OR Mini Kit 31141651 K-1560-S OR Mini Kit 31141669 K-1530-S OR Mini Kit 31141677 K-1200-S OR Mini Kit 31141784 K-1960-S OR Mini Kit 31141859 K-1615-S3 OR Mini Kit 31141875 K-1940-S3 OR Mini Kit 31145025 7496-8 MINI-PLUS KIT 31145397 7497-8 MINI-PLUS KIT 31145413 7497-88 Mini-Plus Kit 31150470 7496-PUP MINI PLUS KIT 50000148 K-1920-COE MINI-KIT 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 573375A MINI-PLUS KIT
|
Code Information |
Lot number begins 508xxxx or lower |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact |
Catherine Wrenn 203-492-5415
|
Manufacturer Reason for Recall |
Devon Light Gloves contain splits or holes compromising the sterility
|
FDA Determined Cause 2 |
Process control |
Action |
Medtronic/Covidien initiated recall on April 16, 2015 via FedEx and certified mail
Customers were instructed to discontinue use of the product and return all inventory and kits to Medtronic (Covidien) -Attention: Devon" Light Glove 110 Kendall Park Lane. Atlanta, GA 30336.
If you have any questions contact your Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am to 6:30pm ET,
at (800) 882-5878. |
Quantity in Commerce |
559,108 kits |
Distribution |
Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|