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- Baxa Repeater Pump Technical Manual Transmission
- Baxa Repeater Pump Manual Pdf
- Baxter Repeater Pump Manual Pdf
- Baxa Repeater Pump Manual
| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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Baxa Repeater Pump Technical Manual Transmission
Baxa Repeater Pump Manual Pdf
| New Search | Back to Search Results |
| | Class 2 Device Recall Repeater Pump |
| Date Initiated by Firm | October 03, 2012 |
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| Date Posted | October 25, 2012 |
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| Recall Status1 | Terminated 3 on February 15, 2013 |
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| Z-0156-2013 |
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| Recall Event ID | 63379 |
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System/device, pharmacy compounding - Product CodeNEP
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| Product | 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. |
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| Code Information | Repeater Pump model #s 095, 099, and 099R. |
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Recalling Firm/
Manufacturer | Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
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| For Additional Information Contact |
303-690-4204 |
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| 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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| Packaging process control |
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| Baxa Corporation sent a 'REPEATER PUMP PRODUCT NOTICE' to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received a CD containing a copy of the correct Operator Mannual, 5300-0754. Contact Technical Support at 800-678-2292 for questions regarding this notice. |
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| Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela. |
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| TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. |
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Baxter Repeater Pump Manual Pdf
Baxa Repeater Pump Manual
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