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FDAFDA · Food and drugs·Recall number Z-1352-2025

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

Published March 26, 2025 · Recall initiated: February 6, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
American Contract Systems Inc
Distributor
US Nationwide distribution in the state of OH.
Lot
UDI-DI 00191072167491 00191072218698 Lots 971241 947241 926241 894241 70-051029 70-051995 70-052417 70-052771
Risk classification
Class II
Area (FDA)
device
Country
United States

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