FDA recall Z-1920-2026

Windstone Medical Packaging, Inc. · Class II · device

Product

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

Reason for recall

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).

Distribution

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

Key facts

Status
Ongoing
Initiation date
2026-03-11
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1920-2026