Pad, Alcohol, Device Disinfectant
FDA product code LKB · Unclassified · General Hospital
25510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Aplicare, Inc. 4
- Concord Laboratories, Inc. 3
- Span-America Medical Systems, Inc. 3
- Holtsch Co., Inc. 1
- Professional Disposables International, Inc. 1
- Becton Dickinson & Co. 1
- C.R. Bard, Inc. 1
- Medical Device Inspection Co., Inc. 1
- Westlock Investments (Usa), Inc. 1
- Specialites Septodont 1
- Bowen & Company, Inc. 1
- Norpak Mfg., Inc. 1
- Beckman Instruments, Inc. 1
- Bausch & Lomb, Inc. 1
- H & P Industries, Inc. 1
- Ellis Pharmaceutical Consulting, Inc. 1
- Acme United Corp. 1
- Cederroth, Inc. USA 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132380 | Prevantics Device SwabLKB · Traditional | Professional Disposables International, Inc. | 08/27/2014SE |
| K121655 | BD Alcohol SwabLKB · Traditional | Becton, Dickinson & CO | 03/20/2013SE |
| K112791 | Sitescrub Ipa DeviceLKB · Traditional | C. R. Bard | 02/24/2012SE |
| K912161 | I.V. Starr KitLKB · Traditional | Medical Device Inspection Co., Inc. | 10/08/1991SE |
| K912731 | Steri-SwabLKB · Traditional | Westlock Investments (Usa), Inc. | 10/02/1991SE |
| K910735 | Hexidis Alcohol SwabLKB · Traditional | Specialites Septodont | 04/02/1991SE |
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | Bowen & Company, Inc. | 04/04/1990SE |
| K896835 | Alcohol Prep and Povidone-Iodine PrepLKB · Traditional | Norpak Mfg., Inc. | 01/11/1990SE |
| K894791 | Baxter Acetone-Alcohol Swabstick, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K893958 | Baxter Acetone-Alcohol Prep Pads, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K892193 | Quickpad (Alcohol Swabs)LKB · Traditional | Holtsch Co., Inc. | 08/04/1989SE |
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | Concord Laboratories, Inc. | 05/16/1989SESD |
| K890514 | Pre-Moistened Cleansing PadLKB · Traditional | Bausch & Lomb, Inc. | 04/10/1989SE |
| K870718 | American Alcohol Prep Pad Sterile MediumLKB · Traditional | Span-America Medical Systems, Inc. | 05/07/1987SE |
| K860961 | Gamma Radiation Sterilized Alcohol Prep PadsLKB · Traditional | H & P Industries, Inc. | 04/09/1986SE |
| K852235 | Sterets Injection SwabLKB · Traditional | Ellis Pharmaceutical Consulting, Inc. | 06/07/1985SE |
| K833993 | Alcohol SwabsLKB · Traditional | Concord Laboratories, Inc. | 01/30/1984SE |
| K833936 | Acetone Alcohol SwabsLKB · Traditional | Concord Laboratories, Inc. | 01/30/1984SE |
| K833185 | Acetone Alcohol Prep PadLKB · Traditional | Aplicare, Inc. | 10/31/1983SE |
| K833183 | Aplicare One Acetone Alcohol SwabstickLKB · Traditional | Aplicare, Inc. | 10/31/1983SE |
| K833141 | One Time Acetone/Alcohol;Swab SticksLKB · Traditional | Acme United Corp. | 10/31/1983SE |
| K833184 | Aplicare Three Alcohol SwabsticksLKB · Traditional | Aplicare, Inc. | 10/27/1983SE |
| K833182 | Aplicare Alcohol Prep PadLKB · Traditional | Aplicare, Inc. | 10/27/1983SE |
| K830330 | Savett Alcohol PrepLKB · Traditional | Cederroth, Inc. USA | 03/17/1983SE |
| K813391 | Tobramycin Reagent Test KitLKB · Traditional | Beckman Instruments, Inc. | 12/18/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1455-2024 Class II | MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1622-2022 Class II | Dynarex PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-2211-2017 Class II | Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305ZProduct is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. | Madison Polymeric Engineering | 04/17/2017Terminated |
| Z-2595-2014 Class II | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile.…Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to… | Catheter Connections, Inc. | 08/05/2014Terminated |
| Z-0188-2012 | PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box.…Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due… | Alere San Diego | 10/11/2011Terminated |
| Z-2391-2011 | Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | Vygon Corporation | 04/19/2011Terminated |
| Z-2390-2011 | Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | Vygon Corporation | 04/19/2011Terminated |
| Z-2389-2011 | Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | Vygon Corporation | 04/19/2011Terminated |
| Z-2388-2011 | Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | Vygon Corporation | 04/19/2011Terminated |