FDAClass IIMarch 26, 2025

Labor & Delivery Pack recall

LABOR & DELIVERY PACK, Model Nos LLLD19H

Why was Labor & Delivery Pack 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00191072219213 Lots 885241 70-051324 70-051967 70-052455 70-053006

Product
LABOR & DELIVERY PACK, Model Nos LLLD19H
Recalling firm
American Contract Systems Inc
Quantity
725 kits
Distribution
US Nationwide distribution in the state of OH.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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