FDAClass IISeptember 4, 2019

Dosi-fuser 12591 5-500d1 -usa recall

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

Why was Dosi-fuser 12591 5-500d1 -usa recalled?

The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

Product
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Recalling firm
Leventon S. A. U.
Quantity
1700
Distribution
US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Recall date
September 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls