Recall Z-2146-2010
Baxa Corporation · initiated May 26, 2010
Product
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
Codes / lots: All lot numbers
Reason for recall
Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
FDA-determined cause: Process design
Action taken
Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.
Details
- Recall number
- Z-2146-2010
- Initiated
- May 26, 2010
- Posted by FDA
- August 2, 2010
- Terminated
- August 4, 2011
- Product code
- KPE – Container, I.V.
- Quantity
- 410,050 units
- Distribution
- Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay.
- Recalling firm
- Baxa Corporation, Englewood, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2137-2010 | Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2138-2010 | Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2139-2010 | Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2140-2010 | Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2141-2010 | Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2142-2010 | Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2143-2010 | Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2144-2010 | Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2145-2010 | Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2147-2010 | Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |
| Z-2148-2010 | Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | 05/26/2010Terminated |