Recalls / —
—#137911
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
- FDA product code
- FSY — Light, Surgical, Ceiling Mounted
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot number begins 508xxxx or lower
Why it was recalled
Devon Light Gloves contain splits or holes compromising the sterility
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2015-04-16
- Posted by FDA
- 2015-07-20
- Terminated
- 2017-06-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #137911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.