IV Administration Sets from Windstone Medical for Infusion Pump Systems
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classification is Class II, and the hazard (backflow and priming failure in IV administration) poses a risk of harm to patients receiving IV therapy. No illnesses or injuries are reported in the source text, which limits the score to 3 per the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Custom Convenience Kits Pre Op Kit (Part Number AMS14994) due to a voluntary medical device correction initiated by B Braun. The kits contain gravity IV administration sets and pump administration sets designed for use with B Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
The potential hazard is backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections, as well as the ability to prime (occlusion). These conditions could compromise the integrity of IV therapy delivery.
A total of 380 units were distributed nationwide in the states of Georgia, Oregon, Tennessee, and Washington. The affected lot numbers are 220039, 221423, 224226, 224793, and 225009 (UDI-DI: B098AMS149940).
Patients and healthcare providers should contact Windstone Medical Packaging or B Braun for information regarding this voluntary correction and appropriate action regarding use of these kits.
The recalled product
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- backflow
- medication-error
- infusion-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: B098AMS149940
- Lot Numbers: 220039 221423 224226 224793 225009
Distribution
Distributed nationwide across the United States.
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