Recall Z-1420-2012 ยท LHI Set, I.V. Fluid Transfer
Baxa Corporation
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.
| Date | Apr 13, 2012 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 347,494 cases/ 50 bags each |
| Distribution | Worldwide Distribution -- USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |