Recalls / —

—#210312

Product

smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

FDA product code

BYD — Condenser, Heat And Moisture (Artificial Nose)

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057

Why it was recalled

Uncertainty in the seal integrity of the sterile packaging.

Root cause (FDA determination)

Packaging process control

Action the firm took

Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact smithsmedical.@sedgwick.com.

Recalling firm

Firm

Smiths Medical ASD Inc.

Address

6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern

Worldwide distribution.

Timeline

Recall initiated

2024-07-18

Posted by FDA

2024-10-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #210312. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.