FDAClass IIApril 10, 2024

Medline M1s0179 Strl Tape/pen Pack recall: Sterility Concern

MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A

Why was Medline M1s0179 Strl Tape/pen Pack recalled?

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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 20193489111375 (case) 10193489111378 (each), Lot Numbers: 2023031590, 2023070390

Product
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
4200 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Recall date
April 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls