Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1921-2026 — Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

U.S. FDA — Device Enforcement · United States · 2026-03-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1921-2026
Date of alert
2026-03-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Windstone Medical Packaging, Inc.
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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