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U.S. Department of Health and Human Services

Class 2 Device Recall Baxa EVA TPN bags

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 Class 2 Recall
Baxa EVA TPN bags
see related information
Date Posted April 13, 2012
Recall Status1 Terminated on April 13, 2012
Recall Number Z-1420-2012
Recall Event ID 52120
Premarket Notification
510(K) Number
K900585 
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Baxa Corporation
14445 Grasslands Dr
Englewood, Colorado 80112
Manufacturer Reason
for Recall
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
FDA Determined
Cause 2
MISBRANDING: 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 in Commerce 347,494 cases/ 50 bags each
Distribution Worldwide Distribution -- USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.
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