Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Custom Convenience Kits Pre Op Kits Recalled for IV Set Backflow Risk

Agency Publication Date: April 22, 2026
Share:
Sign in to monitor this recall

Summary

Windstone Medical Packaging, Inc. is recalling approximately 1,375 Custom Convenience Kits Pre Op Kits containing B Braun IV administration sets. These gravity and pump administration sets have a defect that can cause medication to flow backward from secondary (piggyback) containers into the primary IV container or other connections. This defect can also cause the device to fail during priming due to an occlusion. No injuries or incidents have been reported to date, but the kits were distributed to medical facilities in Georgia, Oregon, Tennessee, and Washington.

Risk

The defect allows medication to flow in the wrong direction within the IV tubing, which may result in a patient receiving an incorrect dose of medication or a delay in therapy if the device cannot be properly prepared (primed).

What You Should Do

  1. Stop using the recalled Custom Convenience Kits Pre Op Kits immediately.
  2. Check your inventory for Custom Convenience Kits Pre Op Kits with part numbers AMS14433, AMS14994, or AMS14994A.
  3. Identify affected products by checking the lot numbers and UDI-DI codes printed on the kit packaging. See the Affected Products section below for the full list of affected codes.
  4. Contact Windstone Medical Packaging, Inc. or your distributor to arrange for the return, replacement, or correction of the affected kits.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report a problem.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Custom Convenience Kits Pre Op Kit - NS
Model / REF:
AMS14433
Lot Numbers:
204612
206723
210211
213641
216064
222060
224073
225012
236012
236910
UDI:
B098AMS144330

Quantity affected: 475 units

Product: Custom Convenience Kits Pre Op Kit - NS
Model / REF:
AMS14994
Lot Numbers:
220039
221423
224226
224793
225009
UDI:
B098AMS149940

Quantity affected: 380 units

Product: Custom Convenience Kits Pre Op Kit - NS
Model / REF:
AMS14994A
Lot Numbers:
224792
228566
230105
230853
234209
UDI:
B098AMS14994A0

Quantity affected: 520 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98659
Status: Active
Manufacturer: Windstone Medical Packaging, Inc.
Sold By: Hospitals; Surgical centers; Medical facilities
Manufactured In: United States
Units Affected: 1,375
Distributed To: Georgia, Oregon, Tennessee, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.