Covidien LLC: Devon Light Gloves contain splits or holes compromising the sterility

Agency Publication Date: July 20, 2015

Affected Products

Product: Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE

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Product: Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT

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Product: Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31141578 K-1840-S OR Mini Kit 31141586 K-1660-S OR Mini Kit 31141602 K-1630-S OR Mini Kit 31141610 K-1615-S OR Mini Kit 31141628 K-1614-S OR Mini Kit 31141651 K-1560-S OR Mini Kit 31141669 K-1530-S OR Mini Kit 31141

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Product: 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

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Product: Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Ki

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Product: ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

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Product: 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 314514

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Product: Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit

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Product: Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT

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Product: Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin Kit

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

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Product: NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711

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Product: Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074

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Product: Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71113

Status: Resolved

Manufacturer: Covidien LLC

Manufactured In: United States

Units Affected: 13 products (26,108,946 units; 8,630 units; 559,108 kits; 81,252 kits; 33,256 kits; 4,136 kits; 114,813 kits; 5,786 kits; 5,160 kit; 77,588 kits; 144 kits; 385486; 23560)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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Lot number begins 508xxxx or lower

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number

Lot number begins 508xxxx or lower

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Product: Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT

Lot number begins 508xxxx or lower

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number

Lot number begins 508xxxx or lower

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number

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

Lot number begins 508xxxx or lower

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number

Product: NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711

Lot number begins 508xxxx or lower

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number

Lot number begins 508xxxx or lower

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number

Product: Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK

Lot number begins 508xxxx or lower

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number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71113

Status: Resolved

Manufacturer: Covidien LLC

Manufactured In: United States

Units Affected: 13 products (26,108,946 units; 8,630 units; 559,108 kits; 81,252 kits; 33,256 kits; 4,136 kits; 114,813 kits; 5,786 kits; 5,160 kit; 77,588 kits; 144 kits; 385486; 23560)