Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A dispos...
FDA Device Recall #Z-0365-2017 — Class II — September 29, 2016
Recall Summary
| Recall Number | Z-0365-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 29, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien LLC |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 118,800 |
Product Description
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 for Recall
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Lot / Code Information
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 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31141586 K-1660-S STD. MINI-KIT STER. 31141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD,MINI-PLUS KIT 31145496 7696-T4 STANDARD SURGI-START 31145504 7708 STANDARD SURGI-START KIT 31145520 7614 SURGI-START KIT STERILE 31145546 7693 SURGI-START KIT STERILE 31145629 7696 STANDARD SURGI-START KIT 31145645 7608 SURGI START KIT STERILE 31149720 7496-NNB VAR. MINI PLUS KIT 31150470 7496-PUP VAR. MINI PLUS KIT 31152302 7896-NNB VAR. SURGI-START KIT 31153060 7697-T4 SURGI-START KIT 31153938 7756-KST VAR.SURGI-START KIT 31154266 7656-KST VAR. SURGI-START KIT 31175089 7497-8T6 STD MINI-KIT PLUS 31175105 7553-NAL VARIATION BUNNY KIT 31314720 7514-CCS VARIATION BUNNY KIT 31321097 7697 STD SURGI-START KIT 31324299 7830-HOH STD PLUS SURGI-START 31361234 7460-CNR2 MINI-PLUS KIT STD KT 31404851 BIRTHDAY KIT STANDARD PLUS 31451092 7600-DNV SURGI-START KIT STD 31451480 7493-SFW MINI-PLUS KIT STD 31453098 7682-MHP SURGI-START STD PLUS 31457131 7461-SMS MINI-PLUS KIT STD PLU 31460432 7596-SHH STD PLUS BUNNY KIT 50000148 K-1920-COE MINI-KT STAND-PLUS 50000510 7500-END STANDARD SURGICAL KIT 50000511 7516-UNI STANDARD SURGICAL KIT 50000512 7557-UNI UNIVERSAL SURGICAL KT 50000515 7667-BRT SURGI-START KIT STRD. 50000568 7605-SEC SURGI STANDARD PLUS K 50000599 7694-ADA SURGI-START KIT 50000947 7413-CAD MINI-PLUS KIT 50000980 7897-SME SURGI-START KIT 50001029 7417-PCP MINI-PLUS KIT 50001033 7520-FSF MINOR KIT 50001052 7427-CFS MINI-PLUS KIT 50001057 7484-HHS MINI-PLUS KIT 50007698 7698-T4 STANDARD SURGI-START K 50007699 7699-T4 STANDARD SURGI-STAR 50007898 7898-T8 STANDARD SURGI-START K 50007899 7899-T8 STANDARD SURGI-START K 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 52000076E C-SECTION PACK 52000082E DELIVERY KIT 573375A MINI-PLUS KIT 573830D MINOR KIT 573831B MAJOR KIT
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| Z-1319-2022 | Class I | Palindrome HSI Chronic Catheter, Sterile, Singl... | Jun 8, 2022 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.