The Food and Drug Administration (FDA), United States, has issued a Class II recall on EVA TPN bags, manufactured by Baxa Corporations Inc.. The product is sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags. The model numbers involved included the following:
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.
The FDA found that the Spike port of EVA TPN Bags contains low levels of DEHP which could leach out. Current Baxa product is mislabeled as non-DEHP. The manufacturer is working with the supplier to replace the spike port with a non-DEHP as soon as possible.
According to the local supplier, the affected products have been distributed in Hong Kong.
For details, please refer to FDA website
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm300959.htm
If you are in possession of the product, please contact your supplier for necessary actions.