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

FDA device recall Z-1472-2015 · posted 2015-04-21 · Terminated

Recall details

Recalling firm

Churchill Medical Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

FPA

Quantity affected

0

Distribution

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

Date initiated

2015-01-15

Date posted

2015-04-21

Date terminated

2016-02-25

Location

Dover, NH

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