Which brands are affected?

The following brands are affected: Windstone Medical Packaging.

HIGHMarch 11, 2026

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Q: Which model numbers are affected?

Affected models: UDI-DI: B098AMS14994A0, Lot Numbers: 224792 228566 230105 230853 234209.

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

1Stop using the product until you confirm whether it is included in the recall.
2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand: Windstone Medical Packaging
Model numbers: UDI-DI: B098AMS14994A0, Lot Numbers: 224792 228566 230105 230853 234209
Where affected: ALL

Hazard Information

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.

View Original Recall on FDA - Medical Devices