—#210758

Product

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

FDA product code: BSR — Stylet, Tracheal Tube
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Smiths Medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 10/28/2024, mailed using a traceable means. The notice explained the issue, potential risk, and requested the consignee locate and destroy all affected products, and distribute the notice to all affected parties. Distributors were directed to notify their customers. For questions: About the communication: smithsmedical7602@sedgwick.com, 1-800-913-3897; To report adverse events: globalcomplaints@icumed.com, 1-866-216-8806

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-10-28
Posted by FDA: 2024-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210758. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.