Z-2109-2015 Class II Terminated
FDA device recall Z-2109-2015 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: 81,252 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
- 81,252 kits
Product Description
Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR 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-2109-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026