Pad, Alcohol, Device Disinfectant

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-03-29Open, ClassifiedProcess control

  MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723

  Product 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.

• 2022-08-26Open, ClassifiedEnvironmental control

  Dynarex PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• 2017-05-12TerminatedOther

  Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

  Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

• 2014-09-05TerminatedPackaging

  DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

  Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

• 2011-11-16TerminatedMaterial/Component Contamination

  PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio Starter Kit Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere INRatio2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you.

  Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.

• 2011-06-11TerminatedNonconforming Material/Component

  Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit.

  Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

• 2011-06-11TerminatedNonconforming Material/Component

  Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing kit.

  Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

• 2011-06-11TerminatedNonconforming Material/Component

  Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a PICC insertion tray.

  Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.

• 2011-06-11TerminatedNonconforming Material/Component

  Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change Kit.

  Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.