Recall Z-0787-2017 ยท FPA Set, Administration, Intravascular
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
| Date | Nov 18, 2016 |
| Status | Terminated |
| Reason | Incorrect priming volume is printed on the device package. |
| 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 |
| Quantity | 31,500 |
| Distribution | US distribution in the state of CA |
| 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 |