Medical device recalls Moderate risk

Teleflex Medical recalls RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0

Recall date
April 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1686-2019
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
Nationwide

Why it was recalled

The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

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

What was recalled

RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0

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