Medical device recalls Moderate risk

LACERATION TRAY recalled over laceration hazard

Recall date
February 6, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
American Contract Systems Inc recalls LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Recall number
Z-1349-2025
FDA classification
Class II
Brand / firm
American Contract Systems Inc
Sold / distributed
US Nationwide distribution in the state of OH.

Why it was recalled

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

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

What was recalled

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

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