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.
FDA Recall Z-1420-2012 · Posted 2012-04-13
Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeLHI
Date Initiated2009-05-08
Date Terminated2012-04-13
Product Quantity347,494 cases/ 50 bags each
Reason for Recall
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution -- USA (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.