Covidien LLC: Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Is my product affected?

Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

• UPC 31131141602

Check against the official notice below — it lists the full affected range.

What happened

Covidien LLC is recalling Covidien Devon Light Glove products packaged in sterile surgical kits distributed worldwide, including throughout the United States and in multiple foreign countries. The recall affects approximately 13.8 million units distributed in the USA across numerous surgical kit models and lot codes. The Light Glove is a disposable, sterile, single-use cover designed for compatible surgical light handles.

The reason for the recall is an addition to the Instructions for Use requiring that after application, the Light Glove be inspected for barrier integrity. The recall notice does not specify a remedy or what consumers should do in response.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Added Instructions for Use: After application, inspect the Light Glove for barrier integrity

Details from the source

Reason for recall: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Distribution: 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 Quantity: 13,786,893 in total Distributed in USA Lot/code info: All lot codes in the following kits: 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. 31131141602 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 3114185

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX F2016-09-30
• Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or tu2016-09-27
• EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high2016-09-27
• PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for 2016-09-19
• RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative dis2016-09-16

All FDA (Device enforcement) recalls