Home / Recalls / Covidien LLC / Z-2112-2015

Z-2112-2015 Class II Terminated

Recalled by Covidien LLC — North Haven, CT

FDA device recall Z-2112-2015 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: 114,813 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
114,813 kits

Product Description

Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical 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-2112-2015
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources