Professional Disposables International, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 1
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0571-2022 | Class II | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as | February 4, 2022 |
| D-0572-2022 | Class II | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, package | February 4, 2022 |
| D-0570-2022 | Class II | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, pa | February 4, 2022 |
| D-0764-2021 | Class II | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, | July 23, 2021 |
| D-0759-2021 | Class II | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeb | July 23, 2021 |
| D-0761-2021 | Class II | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Oran | July 23, 2021 |
| D-0758-2021 | Class II | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables | July 23, 2021 |
| D-0760-2021 | Class II | PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orange | July 23, 2021 |
| D-0762-2021 | Class II | PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable Internatio | July 23, 2021 |
| D-0763-2021 | Class II | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable Internati | July 23, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132380 | PREVANTICS DEVICE SWAB | August 27, 2014 |