Medical device recalls Moderate risk

Olsen Medical recalls Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b)…

Recall date
May 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1945-2018
FDA classification
Class II
Brand / firm
Olsen Medical
Sold / distributed
Worldwide Distribution

Why it was recalled

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

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

What was recalled

Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10

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