Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
This recall has been terminated (originally issued August 2, 2010).
- Company
- Baxa Corporation
- Recall Initiated
- May 26, 2010
- Posted
- August 2, 2010
- Terminated
- August 4, 2011
- Recall Number
- Z-2142-2010
- Quantity
- 263,150 bags
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
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.
Lot / Code Info
All lot numbers
Root 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.