Data / Medical devices / Bone Marrow Collection/Transfusion Kit
Bone Marrow Collection/Transfusion Kit (LWE): 15 FDA-registered makers in 4 countries
15 establishments in 4 countries are registered with the FDA to make Bone Marrow Collection/Transfusion Kit (product code LWE, Class 2). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on July 17, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LWE
- Device class
- 2
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Mexico | 2 |
| Dominican Republic | 1 |
| Honduras | 1 |
Makers of Bone Marrow Collection/Transfusion Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 1 | November 1, 1991 | 0 | 0 | 0 | api.fda.gov |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | November 6, 1987 | 0 | 0 | 0 | api.fda.gov |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 1 | November 6, 1987 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 1 | November 6, 1987 | 0 | 0 | 0 | api.fda.gov |
| Aero-Med LLC | East Hartford, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioaccess, Inc. | Baltimore, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carefusion 2200, Inc. | Mannford, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HPC Medx | Hanover, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Metrix Company | Dubuque, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 17, 1995. 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.