FDA Medical Device Recalls (openFDA)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Recall number
- Z-1484-2017
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Product
- AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Status
- Terminated
- Initiated
- 2017-02-20
- Posted
- not on file
- Terminated
- 2019-04-22
- Reason
- Incorrect priming volume printed on the device package.
- Root cause
- Error in labeling
- Action
- Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at customerservice@vygonus.com.
- Quantity
- 30,700
- Distribution
- US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
- Lot, serial or model codes
- 1610092D 1611091D 1612068D 1612074D
- 510(k) numbers
- ["K021395"]
- 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