Home / Recalls / Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. / Z-0787-2017

Z-0787-2017 Class II Terminated

Recalled by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. — Dover, NH

FDA device recall Z-0787-2017 was initiated by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. on Nov 18, 2016 and is designated Class II. Reason for recall: Incorrect priming volume is printed on the device package. The recall status is terminated (terminated Oct 23, 2017). Affected quantity: 31,500.

Recall details

Product Type: Devices
Report Date: Dec 28, 2016
Initiation Date: Nov 18, 2016
Termination Date: Oct 23, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,500

Product description

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

Reason for recall

Incorrect priming volume is printed on the device package.

Distribution pattern

US distribution in the state of CA

Code information

1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0787-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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