United StatesWindstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit - NS (Part Numbers AMS14433, AMS14994, AMS14994A; UDI-DIs B098AMS144330, B098AMS149940, B098AMS14994A0; Lot numbers 204612, 206723, 210211, 213641, 216064, 222060, 224073, 225012, 236012, 236910, 220039, 221423, 224226, 224793, 225009, 224792, 228566, 230105, 230853, 234209) distributed in the United States, including GA, OR, TN and WA. The recall was initiated because B. Braun issued a voluntary Urgent Medical Device Correction for certain gravity and pump IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
What's being recalled
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Recalling firm: Windstone Medical Packaging, Inc., Billings, MT, United States.
How to identify it
UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910 UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009 UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
The hazard
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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of GA, OR, TN, and WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)