FDA (Devices) recall action 71113

Covidien LLC recalled 14 products on 2015-07-29

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2015-07-29
Critical: 0
Units: 27,407,865

Why these products were recalled

Devon Light Gloves contain splits or holes compromising the sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–14 of 14

HighFDA (Devices)··2015-07-29
FDA Recalls Sterile Single Basin Kits with Compromised Gloves
The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.
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 7
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise
FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.
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 SA
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes
The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.
Product
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise
The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.
Product
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
Category
Distribution
1 state
SevereFDA (Devices)··2015-07-29
FDA Recalls Sterile Surgical Kits with Compromised Gloves
The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.
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
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
FDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
The FDA is recalling sterile Devon Light Gloves because splits or holes compromise their sterility. The recall covers 26,108,946 units distributed worldwide.
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
Category
Distribution
1 state
SevereFDA (Devices)··2015-07-29
Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.
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
Category
Distribution
1 state
SevereFDA (Devices)··2015-07-29
FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves
The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.
Product
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise sterility.
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
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
Surgical Kits Recalled Due to Glove Splits Compromising Sterility
The FDA is recalling 114,813 surgical kits containing Devon Light Gloves due to splits or holes that compromise sterility.
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 74
Category
Distribution
1 state
SevereFDA (Devices)··2015-07-29
FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves
The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.
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
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
Recall of Sterile Major Kits with Defective Devon Light Gloves
FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.
Product
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Category
Distribution
1 state
HighFDA (Devices)··2015-07-29
FDA Recalls Devon Light Gloves for Sterility Compromising Defects
The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.
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 31
Category
Distribution
1 state
SevereFDA (Devices)··2015-07-29
FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.
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
Category
Distribution
1 state