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

FDA device recall Z-0528-2025 · posted 2024-11-25 · Open, Classified

Recall details

Recalling firm

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BSR

Quantity affected

10,223 units

Distribution

Worldwide distribution.

Date initiated

2024-10-28

Date posted

2024-11-25

Location

Minneapolis, MN