Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR K
FDA device recall Z-2109-2015 · posted 2015-07-20 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Devon Light Gloves contain splits or holes compromising the sterility
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 81,252 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 , Fran
- Date initiated
- 2015-04-16
- Date posted
- 2015-07-20
- Date terminated
- 2017-06-28
- Location
- North Haven, CT
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