PlainRecalls
FDA Devices Moderate Class II Terminated

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Reported: July 29, 2015 Initiated: April 16, 2015 #Z-2116-2015

Product Description

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Reason for Recall

Devon Light Gloves contain splits or holes compromising the sterility

Details

Recalling Firm
Covidien LLC
Units Affected
144 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 , 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.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit. Recalled by Covidien LLC. Units affected: 144 kits.
Why was this product recalled?
Devon Light Gloves contain splits or holes compromising the sterility
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2116-2015.