FDAClass IOctober 1, 2014

83" (211 cm) Appx recall

83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV…

Why was 83" (211 cm) Appx 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 # 2801951

Product
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV…
Recalling firm
ICU Medical, Inc.
Quantity
100 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