Baxa Corp.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 40
At a glance
Market reach
- United States
- FDA recalls
What Baxa Corp. makes
Baxa Corp. manufactures medical devices for fluid management and medication delivery, including piston syringes, syringe infusers, and the Microfuse dual rate infuser. Their product portfolio also features the Exacta-Mix 2400 compounding system, the SureConnect closed drug reconstitution and transfer system, and various accessories such as swabbable caps, repeater pump tube sets, and rapid-fill tubesets.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) database. The company is based in the United States.
Catalogue
Piston Syringe Ref K951871
Regimes: 510(k) Registry: 510(k)Swabbable Cap, Model 60205 Ref K070163
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Repeater Pump Ii Tube Sets Ref K062909
Regimes: 510(k) Registry: 510(k)Syringe Infuser Ref K933506
Regimes: 510(k) Registry: 510(k)Rapid-Fill Tubeset, Model 90005 Ref K022523
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Microfuse Dual Rate Infuser Ref K983321
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 40 recalls initiated by Baxa Corp., the earliest on 2003-11-07 and the most recent on 2013-08-22. By recorded status: 40 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 22 Aug 2013 Z-2165-2013 Class II Terminated Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
- 4 Jun 2013 Z-1752-2013 Class II Terminated 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.
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2012
- 3 Oct 2012 Z-0156-2013 Class II Terminated 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.
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- 3 Oct 2012 Z-0156-2013 Class II Terminated 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.
2011
- 8 Mar 2011 Z-1962-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1963-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1964-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1965-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1966-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1967-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
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- 8 Mar 2011 Z-1962-2011 Unclassified (pre-2012) Terminated TPN bags may leak during filling operation, due to bag manufacturing error.
2010
- 26 May 2010 Z-2137-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2137-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
Show the 25 most recent of 40 recalls
2010
- 26 May 2010 Z-2138-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2139-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2140-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2141-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2142-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2143-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2144-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2145-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2146-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2147-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 26 May 2010 Z-2148-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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- 10 Feb 2010 Z-1197-2010 Unclassified (pre-2012) Terminated Molding defect in the valve body causes leaking.
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- 26 May 2010 Z-2138-2010 Unclassified (pre-2012) Terminated Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
2009
- 12 Nov 2009 Z-1030-2010 Unclassified (pre-2012) Terminated TPN bags may leak fluid due to inadequate sealing.
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- 12 Nov 2009 Z-1031-2010 Unclassified (pre-2012) Terminated TPN bags may leak fluid due to inadequate sealing.
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- 12 Nov 2009 Z-1032-2010 Unclassified (pre-2012) Terminated TPN bags may leak fluid due to inadequate sealing.
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- 12 Nov 2009 Z-1030-2010 Unclassified (pre-2012) Terminated TPN bags may leak fluid due to inadequate sealing.
Frequently asked questions
How many devices does Baxa Corp. have in the registry?
The registry currently lists 8 devices for Baxa Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baxa Corp.'s devices?
Among its 8 most recently registered devices, Baxa Corp. has devices listed in FDA 510(k) (8 devices).
What risk classes do Baxa Corp.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Baxa Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Baxa Corp.?
FDA recall records list 40 recalls initiated by Baxa Corp., the most recent initiated on 22 Aug 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Baxa Corp. in the registry?
The most recently registered devices listed for Baxa Corp. include PISTON SYRINGE, SWABBABLE CAP, MODEL 60205, EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 and REPEATER PUMP II TUBE SETS.