Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
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).
Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brand
- Windstone Medical Packaging
- Geographic Scope
- 1 states
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Windstone Medical Packaging, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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Full Description
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A. Reason: 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).. Classification: Class II. Quantity: 520 units. Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.
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