Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Summary
The FDA issued a Class II for Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A by Windstone Medical Packaging, Inc.. Reason: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as wel.
Details
Source
Device Recall
External ID
Z-1921-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Lot/Code Info: UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
Quantity Affected: 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).
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-11
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1921-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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