FDAClass IIMarch 26, 2025

Laparoscopy Pack recall

LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

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?

1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051

Product
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Recalling firm
American Contract Systems Inc
Quantity
303 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