Medical device recalls Moderate risk

Merete Medical GmbH recalls Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

Recall date
January 18, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0650-2022
FDA classification
Class II
Brand / firm
Merete Medical GmbH
Sold / distributed
Domestic: Illinois; Foreign: Germany.

Why it was recalled

Incorrect marketing label (25 mm) was applied to product size 20 mm.

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

What was recalled

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

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