FDAClass IIJuly 19, 2017

18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ recall

18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use…

Why was 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ recalled?

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

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 No. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111

Product
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use…
Recalling firm
ICU Medical, Inc.
Quantity
304 units
Distribution
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls