Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

Recall date
July 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0147-2025
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
Worldwide distribution.

Why it was recalled

Uncertainty in the seal integrity of the sterile packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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