Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS

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).

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

An URGENT: MEDICAL DEVICE CORRECTION notification letter was sent to customers on 3/11/26. AMS requests that you undertake the following activities: 1. Review your inventory for the affected kits, all lots are impacted. 2. Communicate the notification with all personnel that utilize B Braun Admin. Sets contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product notification. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Notification Response Required form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. Please complete the attached AMS Urgent Medical Device Product Notification Response Required form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product, you must complete and return the form. If you have any questions or concerns, please do not hesitate to contact us at fieldcorrectiveaction@alignedmedicalsolutions.com.

• FDA enforcement recordOfficial FDA database entry for Z-1921-2026
• FDA device classification · KDDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Windstone Medical Packaging, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.