Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
This recall has been terminated (originally issued April 13, 2012).
- Company
- Baxa Corporation
- Recall Initiated
- May 8, 2009
- Posted
- April 13, 2012
- Terminated
- April 13, 2012
- Recall Number
- Z-1420-2012
- Quantity
- 347,494 cases/ 50 bags each
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
Distribution
Worldwide Distribution -- USA (nationwide)
Lot / Code Info
Model 137, Size 250 ml, Cat. No. H938 137 3 Model 138, Size 500 ml, Cat No. H938 138 3 Model 139, Size 1000 ml, Cat No. H938 139 3 Model 140, Size 2000 ml,Cat. No. H938 140 3 Model 141, Size 3000 ml, Cat. No. H938 141 3 Model 142, Size 4000 ml, Cat. No. H938 142 3 Model 143, Size 5000 ml, Cat. No. H938 143 3 Model 341, Size 500/3000 ml, Cat No. H938 341 3
Root Cause
Labeling False and Misleading
Action Taken
Baxa sent a Customer Notice letter dated May 8, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Current Baxa product is mislabeled as non-DEHP but this does not present a risk to patients. Baxa is committed to providing products that are non-DEHP. We are working with our supplier to replace the spike port with a non-DEHP as soon as possible. In the meantime, product labeling will be updated to reflect this finding. For further questions please call (303) 690-4204.