smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643
- 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:
- Smiths Medical ASD, Inc.
- Reason for Recall:
- Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Product Codes/Lot Numbers:
REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0528-2025
Related Recalls
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.