Recall Z-1330-2011 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
Churchill Medical Systems 14"Extension Set with SmartSite Injection Item # 43000E Intended use: Intravascular Administration Set
| Date | Feb 16, 2011 (initiated Nov 16, 2010) |
| Status | Terminated |
| Reason | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Root cause | Vendor change control |
| Action | The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return pr |
| Quantity | 19, 750 units |
| Distribution | Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA. |
| 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 |