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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter, MiniCap with PovidoneIodine solution

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 Class 2 Device Recall Baxter, MiniCap with PovidoneIodine solutionsee related information
Date Initiated by FirmJuly 08, 2013
Date PostedJune 30, 2014
Recall Status1 Terminated 3 on June 30, 2014
Recall NumberZ-1945-2014
Recall Event ID 68640
510(K)NumberK895631 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductBaxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Code Information Lot Numbers: GD894535, GD894550
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
224-948-4770
Manufacturer Reason
for Recall		the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
FDA Determined
Cause 2		Packaging change control
ActionAn Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.
Quantity in Commerce20,940 units
DistributionDistributed in the states of AR, TN MO, KS, TX, MS, and AL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDI
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