FDAClass IIJune 14, 2023

Presource Kit recall: Sterility Concern

Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

Why was Presource Kit recalled?

Inadvertently released for distibution without sterility assurance.

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?

Catalog Number: SMA21LPUHJ; Lot Number: 019693

Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Recalling firm
Cardinal Health 200, LLC
Quantity
5 units
Distribution
Distribution in the US to Georgia
Recall date
June 14, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls