Medical device recalls Moderate risk

American Contract Systems Inc recalls LABOR & DELIVERY PACK, Model Nos LLLD19H

Recall date
February 6, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1338-2025
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

LABOR & DELIVERY PACK, Model Nos LLLD19H

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