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Recall Observatory FDA recall evidence

Device product

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Z-1919-2026

March 11, 2026

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 98659
Status
Ongoing
Classification
Class II
Quantity
475 units
Official record key
device-enforcement:Z-1919-2026

Official wording

Reason: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Code information: UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910

Distribution pattern: US Nationwide distribution in the states of GA, OR, TN, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).