FDA DevicesClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Published: April 29, 2026Recall ID: Z-1921-2026Category: devicesCountry: US
Reason for Recall / Hazard
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 Description & Identification
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Additional Source Details
| Field | Value |
|---|---|
| City | Billings |
| State | MT |
| Event id | 98659 |
| Address 1 | 1602 4th Ave N |
| Address 2 | N/A |
| Code info | UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209 |
| Postal code | 59101-1521 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 520 units |
| 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | |
| Center classification date | 20260422 |
Overview
- Recalling FirmWindstone Medical Packaging, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of GA, OR, TN, and WA.