Carefusion 213, LLC: FDA regulatory profile
Carefusion 213, LLC appears in 17 indexed U.S. FDA records: 17 recall records, naming 6 distinct products. Latest dated event: a recall record dated 2026-07-22. Observations run 2026-05-13 to 2026-07-22 — 70 days, 17 dated records across 1 calendar year, busiest 2026 with 17. Recalls: 2 Class I (12%) and 15 Class II (88%); 17 ongoing by lifecycle status, reported 2026-05-13 to 2026-07-22; 17 with an FDA recall number, 17 with an initiation date, across 1 state, grouped into 4 FDA recall events. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: BD ChloraPrep Clear (D-0690-2026, Class II, 2026-07-22), BD ChloraPrep Hi-Lite Orange (D-0643-2026, Class II, 2026-07-08), BD PurPrep (D-0644-2026, Class II, 2026-07-08) and BD ChloraPrep Clear (D-0645-2026, Class II, 2026-07-08). Recalling-firm addresses are recorded in TX. Its recall lines are grouped by the FDA into 4 event identifiers: 98790, 99114, 99217 and 99377.
Regulatory snapshot
| Indexed records | 17 |
|---|---|
| Recall records | 17 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | Class I: 2 · Class II: 15 |
| Recall statuses | Ongoing: 17 |
| First observed | 2026-05-13 |
| Latest observed | 2026-07-22 |
| Latest event type | recall |
| Dated observations | 17 |
| Years covered | 1 |
| Span (days) | 70 |
| Busiest year | 2026 (17 records) |
| Recall states | 1 |
| With recall number | 17 of 17 |
| FDA recall events | 4 |
| Related firms / shortages | 0 / 0 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Recall classification | Class I | 2 | 12% |
| Recall classification | Class II | 15 | 88% |
| Recall status | Ongoing | 17 | 100% |
Recall history (17)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 99217 | 10 | Class II | 2026-07-08 | 2026-07-08 |
| 99114 | 4 | Class II, Class I | 2026-07-01 | 2026-07-01 |
| 98790 | 2 | Class II | 2026-05-13 | 2026-05-13 |
| 99377 | 1 | Class II | 2026-07-22 | 2026-07-22 |
Browse the wider classification index: Class I recalls · Class II recalls.
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v | recall | 1 | 2026-07-22 |
| BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 7 | recall | 1 | 2026-07-01 |
| BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) an | recall | 1 | 2026-07-08 |
| BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70 | recall | 1 | 2026-07-08 |
| BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with is | recall | 1 | 2026-07-08 |
| ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% | recall | 1 | 2026-07-08 |
Source limitations
Built from the 17 ingested FDA records for this firm (17 recall, 0 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.