FDAClass IIAugust 8, 2012

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit recall

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

Why was Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit recalled?

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

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?

Part Number AG8137 510(k) K052865 Lot number 2466161

Product
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Recalling firm
ICU Medical, Inc.
Quantity
N/A
Distribution
Nationwide distribution
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls