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
Reasonleaking pouches
ProductBaxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
Quantity629,280 units
DistributionNationwide Distribution.
Initiated2013-05-21
Classified2013-06-21
Terminated2016-07-14
Recall numberZ-1565-2013
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-1565-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65254/

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