FDA Device recall Z-1920-2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 by Windstone Medical Packaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1920-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-11 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
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).
Identifiers
| code_info | UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1920-2026%22
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