Z-1484-2017 Class II Terminated
FDA device recall Z-1484-2017 was initiated by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. on Feb 20, 2017 and is designated Class II. Reason for recall: Incorrect priming volume printed on the device package. The recall status is terminated (terminated Apr 22, 2019). Affected quantity: 30,700.
Recall details
- Product Type
- Devices
- Report Date
- Mar 29, 2017
- Initiation Date
- Feb 20, 2017
- Termination Date
- Apr 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,700
Product description
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Reason for recall
Incorrect priming volume printed on the device package.
Distribution pattern
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Code information
1610092D 1611091D 1612068D 1612074D
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1484-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026