FDA Medical Device Recalls (openFDA)
Churchill Medical Systems, Inc.: AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
- Recall number
- Z-0813-2014
- Recalling firm
- Churchill Medical Systems, Inc.
- Product
- AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
- Status
- Terminated
- Initiated
- 2014-01-07
- Posted
- 2014-01-23
- Terminated
- 2014-11-03
- Reason
- Defective component may cause extension sets to leak.
- Root cause
- Nonconforming Material/Component
- Action
- Vygon sent an Urgent Medical Device Recall letter dated January 7, 2014 to each customer via courier service and email. The letter identified the affected product, problem and actions to be taken. The recall letter instructs customers to: 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 the customer. Distributors were provided with instructions on how to handle product that was further distributed by them. For questions contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.
- Quantity
- 3850
- Distribution
- US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH
- Lot, serial or model codes
- Lot Number: 1306034, 1307011
- 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