Baxa Corp.
Englewood, CO, US
Baxa Corp. appears in FDA device records in Englewood, CO. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Baxa Corp. between 1994 and 2010. The busiest year on record is 2007, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | LHI | Substantially Equivalent | |
| K070163 | SWABBABLE CAP, MODEL 60205 | ODI | Substantially Equivalent | |
| K062909 | REPEATER PUMP II TUBE SETS | FPA | Substantially Equivalent | |
| K022523 | RAPID-FILL TUBESET, MODEL 90005 | LHI | Substantially Equivalent | |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | LHI | Substantially Equivalent | |
| K951871 | PISTON SYRINGE | FMF | Substantially Equivalent | |
| K933506 | SYRINGE INFUSER | FRN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2165-2013 | Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer. | Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date. | Class II | Terminated | |
| Z-1752-2013 | ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. | Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010. | Class II | Terminated | |
| Z-0156-2013 | Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. | The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain