Z-1329-2011

Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451

Name: Z-1329-2011 Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451
Creator: Churchill Medical Systems, Inc.
Published: 2010-11-16
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2010-11-16 / Terminated / root cause: supplier

FDA source

Churchill Medical Systems, Inc. began a recall of Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use: Intravascular Administration Set on 2010-11-16. The reason FDA records is "Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1329-2011
Status: Terminated
Initiated: 2010-11-16
Posted: 2011-02-16
Terminated: 2012-05-01
Recalling firm: Vygon Mfg
Product: Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use: Intravascular Administration Set
Product code: FPA Set, Administration, Intravascular
Reason for recall: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at [email protected].
Quantity in commerce: 100 units
Distribution: Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.
Product codes and lots: Lot Number: 1010018

Product code FPA

K011336Class IIPrimary Solution Set with Universal Spike, Injection Site and Male Luer LockChurchill Medical Systems, Inc. / cleared 2001-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)