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Recall Observatory FDA recall evidence

Device product

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Z-0577-2022

January 07, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 89327
Status
Ongoing
Classification
Class II
Quantity
58,194 units
Official record key
device-enforcement:Z-0577-2022

Official wording

Reason: Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Code information: All lot numbers within expiry

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.