FDAClass IIApril 29, 2015

4" Microbore Double Lumen Set with Bionector recall

4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

Why was 4" Microbore Double Lumen Set with Bionector 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?

1303123 1305003 1305008 1305049 1306097

Product
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Recalling firm
Churchill Medical Systems, Inc.
Quantity
2350
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