Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, E
FDA device recall Z-1420-2012 · posted 2012-04-13 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 347,494 cases/ 50 bags each
- Distribution
- Worldwide Distribution -- USA (nationwide)
- Date initiated
- 2009-05-08
- Date posted
- 2012-04-13
- Date terminated
- 2012-04-13
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (K900585) | Baxa Corp., Sub. of Cook Group, Inc. | 1990-04-18 |