FDAClass IIApril 29, 2015

4" Trifurcated set with Bionectors and check valves recall

4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids

Why was 4" Trifurcated set with Bionectors and check valves 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?

1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101

Product
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
Recalling firm
Churchill Medical Systems, Inc.
Quantity
2650
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