FDA Device Intelligence
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Pad, Alcohol, Device Disinfectant

FDA product code LKB · Class U · Unknown

85
Registered devices
345
Adverse events
9
Recalls
25
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2017-04-17Madison Polymeric EngineeringProduct is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
2014-08-05Catheter Connections, Inc.Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render
2011-10-11Alere San DiegoAlere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microo
2011-04-19Vygon CorporationSkin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to poten
2011-04-19Vygon CorporationSkin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to poten
2011-04-19Vygon CorporationSkin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to poten
2011-04-19Vygon CorporationSkin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to poten

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.