Stop using nowMedical device recall · FDA · Published March 11, 2026
Windstone Custom Convenience Kits Pre Op Kit Recall: Backflow Risk
Windstone Medical Packaging recalls Custom Convenience Kits Pre Op Kit (AMS14994) due to potential backflow of medication between IV containers, risking contamination. Affected units include specific lot numbers.
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).
Take action
Contact the company
📍Recalling firmWindstone Medical Packaging, Inc.1602 4th Ave N · Billings, MT 59101-1521
✎ GovInfoNow plain-language explainer
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit (Part Number AMS149:994) because it can cause medication to flow backward between IV containers, potentially causing contamination. This is a serious risk for patients receiving IV treatments. Read more at govinfonow.com/recall/49749-windstone-custom-convenience-kits-pre-op-kit-recall-backflow-risk.
“Windstone Custom Convenience Kits Pre Op Kit Recall: Backflow Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49749-windstone-custom-convenience-kits-pre-op-kit-recall-backflow-risk. Based on FDA recall #Z-1920-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1920-2026%22&limit=1).
The FDA announced on March 11, 2026, that Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit - NS (Part Number AMS14994) due to potential backflow of medication. The agency issued recall number Z-1920-2026 for the Class II device.
How to tell if you have it
Brand: Windstone Medical Packaging
Product: Custom Convenience Kits Pre Op Kit - NS
Part Number: AMS14994
Lot Numbers: 220039, 221423, 224226, 224793, 225009
Units affected: 380
The hazard
The recall was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets and pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. The hazard involves the potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Context
GovInfoNow's records show Windstone Medical Packaging has 14 other recalls on record since October 24, 2017. Other recent recalls of similar products include B Braun Anesthesia IV Set Recall: Backflow Risk in IV Administration (October 29, 2025) and B Braun Medical IV Sets Recall: Risk of Medication Backflow (October 29, 2025).
How to tell if you have this one
Check for the part number AMS14994 on the kit. Affected units have specific lot numbers: 220039, 221423, 224226, 224793, 225009.
Brand
Windstone Medical Packaging
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
Recall number
Product, codes & lots
Quantity
Z-1919-2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433; UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910
475 units
Z-1920-2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994; UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009
380 units
Z-1921-2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A; UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
520 units
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the Custom Convenience Kits Pre Op Kit (Part Number AMS14994) if it has the listed lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, OR, TN, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Oregon, Tennessee, Washington.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1920-2026 (March 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1920-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.