FDAClass IIJanuary 1, 2025

Rummell recall: Sterility Concern

RUMMELL, Medline Item No. ST006ST

Why was Rummell recalled?

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and 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: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490

Product
RUMMELL, Medline Item No. ST006ST
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
21,440 total
Distribution
US Nationwide distribution.
Recall date
January 1, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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