FDAClass IIMarch 26, 2025

Laparoscopy Pack recall

LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02

Why was Laparoscopy 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 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048

Product
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Recalling firm
American Contract Systems Inc
Quantity
630 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