FDA Medical Device Recalls (openFDA)
Vygon Corporation: Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
- Recall number
- Z-1804-2012
- Recalling firm
- Vygon Corporation
- Product
- Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
- Status
- Terminated
- Initiated
- 2012-05-11
- Posted
- 2012-06-13
- Terminated
- 2013-03-11
- Reason
- Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
- Root cause
- Nonconforming Material/Component
- Action
- VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.
- Quantity
- not on file
- Distribution
- Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
- Lot, serial or model codes
- Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.
- 510(k) numbers
- ["K061497"]
- PMA numbers
- not on file
- Product code
- NZW
- Firm FEI
- 2245270
- Firm city
- Montgomeryville
- Firm state
- PA
- 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