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Class 2 Device Recall Covidien |
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Date Initiated by Firm |
April 16, 2015 |
Date Posted |
July 20, 2015 |
Recall Status1 |
Terminated 3 on June 28, 2017 |
Recall Number |
Z-2111-2015 |
Recall Event ID |
71113 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
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Code Information |
Lot number begins 508xxxx or lower |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
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For Additional Information Contact |
Catherine Wrenn 203-492-5415
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Manufacturer Reason for Recall |
Devon Light Gloves contain splits or holes compromising the sterility
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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 |
4,136 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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