Z-2111-2015 Class II Terminated
FDA device recall Z-2111-2015 was initiated by Covidien LLC on Apr 16, 2015 and is designated Class II. Reason for recall: Devon Light Gloves contain splits or holes compromising the sterility The recall status is terminated (terminated Jun 28, 2017). Affected quantity: 4,136 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- Apr 16, 2015
- Termination Date
- Jun 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,136 kits
Product Description
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
Reason for Recall
Devon Light Gloves contain splits or holes compromising the sterility
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.
Code Information
Lot number begins 508xxxx or lower
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2111-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026