FDAClass IIOctober 30, 2024

Medline DIALYSIS PACK recall: Sterility Concern

Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

Why was Medline DIALYSIS PACK recalled?

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

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 40195327429752 (each), 10195327429751 (case), Lot Numbers: 23LBL499

Product
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
90 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Recall date
October 30, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls