FDAClass IISeptember 18, 2024

Anesthesia Turnover KIT recall: Sterility Concern

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377

Why was Anesthesia Turnover KIT recalled?

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

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 Case 40195327231126, UDI/DI Each 10195327231125; Lot Numbers: 22LBM357

Product
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
105 units
Distribution
US: TX, IL, CA
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls