FDAClass IIApril 13, 2022

Lum Lam Custom Pack - Anesthesia Kit recall: Sterility Concern

Lum Lam Custom Pack - Anesthesia Kit

Why was Lum Lam Custom Pack - Anesthesia Kit recalled?

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

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?

SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685

Product
Lum Lam Custom Pack - Anesthesia Kit
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare
Quantity
21 units
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Recall date
April 13, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls