Z-0787-2017Class II

AMS-651, 120" Microbore extension set with slide clamp

Name: Z-0787-2017 AMS-651, 120" Microbore extension set with slide clamp
Creator: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Published: 2016-11-18
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2016-11-18 / Terminated / root cause: design

FDA source

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. began a recall of AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids on 2016-11-18. FDA classified it as Class II and gives the reason as "Incorrect priming volume is printed on the device package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0787-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Posted: 2016-12-18
Terminated: 2017-10-23
Recalling firm: Vygon Mfg
Product: AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Incorrect priming volume is printed on the device package.
Root cause tag: design
FDA root cause: Device Design
Action: Vygon sent an Urgent Medical Device Recall letter dated November 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 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. For questions contact local sales representative or Vygon's Customer Service Department at 1-800-473-5414.or by email at [email protected].
Quantity in commerce: 31,500
Distribution: US distribution in the state of CA
Product codes and lots: 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0787-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0787-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-18

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)