Recall Z-0813-2014 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
| Date | Jan 23, 2014 (initiated Jan 7, 2014) |
| Status | Terminated |
| Reason | Defective component may cause extension sets to leak. |
| Root cause | Nonconforming Material/Component |
| Action | Vygon sent an Urgent Medical Device Recall letter dated January 7, 2014 to each customer via courier service and email. The letter identified the affected product, problem and actions to be taken. The recall letter instructs customers to: 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 cust |
| Quantity | 3850 |
| Distribution | US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH |
| 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 |