Z-1484-2017Class II

AMS-636, 60" Microbore extension set

Name: Z-1484-2017 AMS-636, 60" Microbore extension set
Creator: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Published: 2017-02-20
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2017-02-20 / Terminated / root cause: labeling and UDI

FDA source

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. began a recall of AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids on 2017-02-20. FDA classified it as Class II and gives the reason as "Incorrect priming volume printed on the device package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1484-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-03-18
Terminated: 2019-04-22
Recalling firm: Vygon Mfg
Product: AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Incorrect priming volume printed on the device package.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 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. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at [email protected].
Quantity in commerce: 30,700
Distribution: US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Product codes and lots: 1610092D 1611091D 1612068D 1612074D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1484-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1484-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-18

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)