| Class 2 Device Recall Covidien | |
Date Initiated by Firm | April 16, 2015 |
Date Posted | July 20, 2015 |
Recall Status1 |
Terminated 3 on June 28, 2017 |
Recall Number | Z-2115-2015 |
Recall Event ID |
71113 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
Product | Single Basin Kits, Sterile-.Kits containing the Devon Light Glove
Catalog Number/Description:
573509 7696-GSL-VL SINGLE BASIN KIT
573558 7665-CPB SINGLE BASIN KIT
573561 7696-KSC SINGLE BASIN KIT
31145645 7608 Single Basin KIT
31153060 7697-T4 Single Basin Kit
50000568 7605-SEC Single Basin Kit
50000599 7694-ADA Single Basin Kit
50007698 7698-T4 Single Basin Kit
50007699 7699-T4 Single Basin 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 | 77,588 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 |
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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.
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