Medline procedure kits labeled as: 1) SHORT TERM recall
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Why was Medline procedure kits labeled as: 1) SHORT TERM recalled?
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
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?
1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case), Lot Numbers: 2024040390, 2024051490, 2024070590, 2024100790.
- Product
- Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1450 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)