FDAClass IIApril 29, 2015

8" Standard Bore Ext Set recall

8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids

Why was 8" Standard Bore Ext Set recalled?

Potential for leaking caused by insufficient bond between needleless device and female luer.

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?

1304129 1305051

Product
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Recalling firm
Churchill Medical Systems, Inc.
Quantity
0
Distribution
Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
Recall date
April 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls