FDA Medical Device Recalls (openFDA)
Churchill Medical Systems, Inc.: 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
- Recall number
- Z-1473-2015
- Recalling firm
- Churchill Medical Systems, Inc.
- Product
- 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 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
- 129,500
- Distribution
- Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
- Lot, serial or model codes
- 1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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