CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Custom Convenience Kits Pre Op Kit - NS recalled
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit - NS, distributed nationwide in the US. The recall was initiated on 11 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1919-2026
- FDA event ID
- 98659
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +42 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Product as listed by the FDA
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Where it was distributed
US Nationwide distribution in the states of GA, OR, TN, and WA.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910
Where was it sold?
US Nationwide distribution in the states of GA, OR, TN, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98659This product is part of a recall event; the main page for the event is Custom Convenience Kits Pre Op Kit - NS recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Custom Convenience Kits Pre Op Kit - NS recalled | Windstone Medical Packaging | Other | Nationwide | |
| CLASS II | Custom Convenience Kits Pre Op Kit - NS recalled | Windstone Medical Packaging | Other | Nationwide |
More recalls from Windstone Medical Packaging
All 337| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
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All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |