Class II

Medical Device Recall: C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

American Contract Systems Inc · February 6, 2025

Reason for Recall

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

Distribution

US Nationwide distribution in the state of OH.

States Affected

NATIONWIDE

Quantity Affected

252 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1336-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.