Recall Z-1484-2017 ยท FPA Set, Administration, Intravascular
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
| Date | Feb 20, 2017 |
| Status | Terminated |
| Reason | Incorrect priming volume printed on the device package. |
| 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 Vyg |
| Quantity | 30,700 |
| Distribution | US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021395 | MODIFICATION TO 30 EXTENSION SET Churchill Medical Systems, Inc., May 13, 2002 |