CareFusion 213, LLC
CareFusion 213, LLC appears in FDA public data with 48 recalls — including 15 Class I (most serious) —, 0 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0690-2026, Class II) was initiated on July 9, 2026.
Summary
- Total Recalls
- 48 (15 Class I)
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0690-2026 | Class II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL | July 9, 2026 |
| D-0649-2026 | Class II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packa | June 11, 2026 |
| D-0647-2026 | Class II | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) p | June 11, 2026 |
| D-0651-2026 | Class II | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL | June 11, 2026 |
| D-0646-2026 | Class II | ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x | June 11, 2026 |
| D-0650-2026 | Class II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packa | June 11, 2026 |
| D-0648-2026 | Class II | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) p | June 11, 2026 |
| D-0645-2026 | Class II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Pac | June 11, 2026 |
| D-0652-2026 | Class II | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 | June 11, 2026 |
| D-0643-2026 | Class II | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I | June 11, 2026 |
| D-0644-2026 | Class II | BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 5 | June 11, 2026 |
| D-0624-2026 | Class I | BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL | May 28, 2026 |
| D-0623-2026 | Class II | BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) | May 28, 2026 |
| D-0622-2026 | Class II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL | May 28, 2026 |
| D-0625-2026 | Class I | BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) | May 28, 2026 |
| D-0518-2026 | Class II | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Steri | April 22, 2026 |
| D-0517-2026 | Class II | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Steri | April 22, 2026 |
| D-0243-2026 | Class II | BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), | December 17, 2025 |
| D-0441-2025 | Class II | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patie | May 15, 2025 |
| D-0259-2025 | Class I | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alco | February 14, 2025 |