Z-0813-2014Class II

AMS-530 7 Microbore Trifurcated Extension sets

Name: Z-0813-2014 AMS-530 7 Microbore Trifurcated Extension sets
Creator: Churchill Medical Systems, Inc.
Published: 2014-01-07
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2014-01-07 / Terminated / root cause: manufacturing process

FDA source

Churchill Medical Systems, Inc. began a recall of AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set on 2014-01-07. FDA classified it as Class II and gives the reason as "Defective component may cause extension sets to leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0813-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-07
Posted: 2014-01-23
Terminated: 2014-11-03
Recalling firm: Vygon Mfg
Product: AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Defective component may cause extension sets to leak.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 3850
Distribution: US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH
Product codes and lots: Lot Number: 1306034, 1307011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0813-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0813-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code FPA

K021395Class IIModification to 30 Extension SetChurchill Medical Systems, Inc. / cleared 2002-05-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)