Medical device recalls Moderate risk

TELEFLEX MEDICAL INC recalls Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

Recall date
January 13, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1269-2020
FDA classification
Class II
Brand / firm
TELEFLEX MEDICAL INC
Sold / distributed
Worldwide

Why it was recalled

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

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

What was recalled

Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

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