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Recall Observatory FDA recall evidence

Device product

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

Z-1945-2014

July 08, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 68640
Status
Terminated
Classification
Class II
Quantity
20,940 units
Official record key
device-enforcement:Z-1945-2014

Official wording

Reason: 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.

Code information: Lot Numbers: GD894535, GD894550

Distribution pattern: Distributed in the states of AR, TN MO, KS, TX, MS, and AL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.