Data / Medical devices / United States / CareFusion 213 LLC
CareFusion 213 LLC: FDA-registered device maker in El Paso, TX, United States, 3 510(k) clearances
CareFusion 213 LLC is registered with the FDA (registration 3004932373) in El Paso, TX, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 25, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004932373
- Address
- 1550 Northwestern DR., El Paso, TX, United States, 79912
- Owner or operator
- CAREFUSION (10030506)
- Roles
- Repackager or relabeler
- First device listed
- October 17, 2022
- Registered through
- 2027
- Brand names listed
- SURGIPHOR, Surgiphor, Surgiphor 1000mL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2026 | K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | FQH | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| February 20, 2026 | K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | FQH | Substantially Equivalent | Bd | accessdata.fda.gov |
| October 14, 2022 | K221504 | BD Surgiphor Antimicrobial Irrigation System | FQH | Substantially Equivalent | Bd | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 4, 2013 | 64585 | Class III | Terminated | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product | An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneo | accessdata.fda.gov |
Compare with other makers
Updated February 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.