FDA Medical Device Recalls (openFDA)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
- Recall number
- Z-0787-2017
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Product
- AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
- Status
- Terminated
- Initiated
- 2016-11-18
- Posted
- not on file
- Terminated
- 2017-10-23
- Reason
- Incorrect priming volume is printed on the device package.
- Root cause
- Device Design
- Action
- Vygon sent an Urgent Medical Device Recall letter dated November 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 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. For questions contact local sales representative or Vygon's Customer Service Department at 1-800-473-5414.or by email at customerservice@vygonus.com.
- Quantity
- 31,500
- Distribution
- US distribution in the state of CA
- Lot, serial or model codes
- 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
- 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