FDA Device recall Z-0365-2017
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible s…
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible s… by Covidien, citing added Instructions for Use: After application, inspect the Light Glove for barrier integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0365-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-29 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Reason
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Identifiers
| code_info | All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KI…All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0365-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.