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

Recall number

Z-1469-2015

Recalling firm

Churchill Medical Systems, Inc.

Product

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

Status

Terminated

Initiated

2015-01-15

Posted

2015-04-21

Terminated

2016-02-25

Reason

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

Root cause

Process design

Action

Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.

Quantity

2350

Distribution

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

Lot, serial or model codes

1303123 1305003 1305008 1305049 1306097

510(k) numbers

["K021395","K070705","K963981"]

PMA numbers

not on file

Product code

FPA

Firm FEI

1000120555

Firm city

Dover

Firm state

NH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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