Class II

Medical Device Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

Windstone Medical Packaging, Inc. · March 11, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

380 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1920-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.