FDAClass IOctober 1, 2014

STAT 2 Flow Controller recall

STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product…

Why was STAT 2 Flow Controller recalled?

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

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?

Lot # 2768416

Product
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product…
Recalling firm
ICU Medical, Inc.
Quantity
3750 units
Distribution
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
Recall date
October 1, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls