FDAClass IIApril 29, 2026

Custom Convenience Kits Pre Op Kit - NS recall

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Why was Custom Convenience Kits Pre Op Kit - NS 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).

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209

Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
520 units
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls