Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
This recall has been terminated (originally issued March 9, 2010).
- Company
- Baxa Corporation
- Recall Initiated
- November 12, 2009
- Posted
- March 9, 2010
- Terminated
- February 24, 2011
- Recall Number
- Z-1030-2010
- Quantity
- 646/50 bag cases
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
TPN bags may leak fluid due to inadequate sealing.
Distribution
Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.
Lot / Code Info
Lot numbers: 738391, 738392.
Root Cause
Process control
Action Taken
Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.
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