Z-0787-2017 Class II Terminated
FDA device recall Z-0787-2017 was initiated by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. on November 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 October 23, 2017). Affected quantity: 31,500.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 18, 2016
- Termination Date
- October 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