RegWardenFDA facility compliance records
Recall

Class II — Baxter Healthcare Corp.

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
Reasonthe 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.
ProductBaxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Quantity20,940 units
DistributionDistributed in the states of AR, TN MO, KS, TX, MS, and AL.
Initiated2013-07-08
Classified2014-06-30
Terminated2014-06-30
Recall numberZ-1945-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-1945-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68640/

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