FDA recall, , Moderate risk
Windstone Medical Packaging Custom Convenience Kits Pre Op Kits
Custom Convenience Kits Pre Op Kit - NS may allow backflow of medication from secondary IV containers into primary containers.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc., of Billings, Montana, began a correction on March 11, 2026, for Custom Convenience Kits Pre Op Kit - NS, after B Braun issued a voluntary Urgent Medical Device Correction for gravity and pump IV administration sets used with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump, due to potential backflow of medication from secondary IV containers into primary containers.
The FDA added the correction to its Enforcement Report on April 22, 2026, and it was in the weekly report on April 29, 2026. The affected kits were distributed in Georgia, Oregon, Tennessee, and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
3 products
Affected if its lot code is listed.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Lot code
- 220039
- 221423
- 224226
- 224793
- 225009
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
- Lot code
- 224792
- 228566
- 230105
- 230853
- 234209
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
- Lot code
- 204612
- 206723
- 210211
- 213641
- 216064
- 222060
- 224073
- 225012
- 236012
- 236910
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Georgia, Oregon, Tennessee, and Washington.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98659
- Recall numbers
- Z-1919-2026 to Z-1921-2026
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
