Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AMS Custom Convenience Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AMS Custom Convenience Kitsee related information
Date Initiated by FirmMarch 11, 2026
Date PostedApril 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1920-2026
Recall Event ID 98659
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductCustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Code Information UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009
FEI Number 1000125955
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact
406-259-6387
Manufacturer 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).
FDA Determined
Cause 2		Process control
ActionAn 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.
Quantity in Commerce380 units
DistributionUS Nationwide distribution in the states of GA, OR, TN, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-