FDAClass IIJuly 31, 2019

Nimbus Administration Set recall

Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle…

Why was Nimbus Administration Set recalled?

Potential for tube leakage

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?

1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022

Product
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle…
Recalling firm
InfuTronix LLC
Quantity
10,800 units
Distribution
US distribution in the state of MA
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls