FDAClass IIMarch 26, 2025

Labor & Delivery PPS recall

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

Why was Labor & Delivery PPS 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 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-052911

Product
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Recalling firm
American Contract Systems Inc
Quantity
1836 kits
Distribution
US Nationwide distribution in the state of OH.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls