IV Administration Sets from Windstone Medical for Infusion Pump Systems
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classification is Class II, and the hazard (backflow and priming failure in IV administration) poses a risk of harm to patients receiving IV therapy. No illnesses or injuries are reported in the source text, which limits the score to 3 per the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Custom Convenience Kits Pre Op Kit (Part Number AMS14994) due to a voluntary medical device correction initiated by B Braun. The kits contain gravity IV administration sets and pump administration sets designed for use with B Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
The potential hazard is backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections, as well as the ability to prime (occlusion). These conditions could compromise the integrity of IV therapy delivery.
A total of 380 units were distributed nationwide in the states of Georgia, Oregon, Tennessee, and Washington. The affected lot numbers are 220039, 221423, 224226, 224793, and 225009 (UDI-DI: B098AMS149940).
Patients and healthcare providers should contact Windstone Medical Packaging or B Braun for information regarding this voluntary correction and appropriate action regarding use of these kits.
The recalled product
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 380
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: B098AMS149940
- Lot Numbers: 220039 221423 224226 224793 225009
Distribution
Part of a larger recall action
This product is one of 3 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Windstone Medical Packaging, Inc.
See all →- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- HighMedical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
Same hazard · backflow
See all →- ModerateIV Administration Sets and Gravity Infusion Kits Risk Backflow
FDA (Devices) · 2026-04-29
- HighIV set 490067 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighUniversal infusion sets recalled over piggyback backflow and priming occlusion
FDA (Devices) · 2025-12-03
- HighIV set 490315 recalled over backflow between primary and secondary containers
FDA (Devices) · 2025-12-03
- HighIV set 490519 recalled over piggyback backflow and priming occlusion
FDA (Devices) · 2025-12-03
Similar recalls
- HighIV set 457504 recalled over medication backflow and priming failure
FDA (Devices) · 2025-12-03
- HighAdministration set 354209 recalled over backflow and inability to prime
FDA (Devices) · 2025-12-03
- HighIV set 352394 recalled over backflow between primary and secondary containers
FDA (Devices) · 2025-12-03
- HighIV administration sets recalled over backflow from piggyback containers
FDA (Devices) · 2025-12-03
- HighIV set 490088 recalled over medication backflow and priming failure
FDA (Devices) · 2025-12-03
- HighGravity IV sets recalled over medication backflow and inability to prime
FDA (Devices) · 2025-12-03