Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF/UDI-DI/Lot(Expiration): K04-00417/00884450046630/I3114667(12/10/2027), I3147550(1/28/2028); K04-00963/00884450046760/H3117053(12/14/2027), H3138590(1/20/2028), H3154108(2/10/2028), H3154786(2/10/2028), H3162244(2/19/2028), H3166789(3/2/2028), H3173526(3/23/2028); K04-01029/00884450148938/H3117059(12/17/2027), H3154112(2/10/2028), H3159017(2/19/2028), H3166777(3/9/2028), H3181994(4/1/2028);
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merit Medical Systems, Inc.
- Reason for Recall:
- High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Product Codes/Lot Numbers:
REF/UDI-DI/Lot(Expiration): K04-00417/00884450046630/I3114667(12/10/2027), I3147550(1/28/2028); K04-00963/00884450046760/H3117053(12/14/2027), H3138590(1/20/2028), H3154108(2/10/2028), H3154786(2/10/2028), H3162244(2/19/2028), H3166789(3/2/2028), H3173526(3/23/2028); K04-01029/00884450148938/H3117059(12/17/2027), H3154112(2/10/2028), H3159017(2/19/2028), H3166777(3/9/2028), H3181994(4/1/2028);
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2294-2025
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Merit Medical Systems
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.