FDAClass IIAugust 8, 2012

High Pressure Stopcock recall

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

Why was High Pressure Stopcock 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 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568

Product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Recalling firm
ICU Medical, Inc.
Quantity
4625
Distribution
Nationwide distribution
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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