Recall Z-2252-2013 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** V
| Date | Sep 18, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | Microbore tubing disconnecting from male luers on the extension sets. |
| Root cause | Under Investigation by firm |
| Action | "Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414. |
| Quantity | 3040 |
| Distribution | Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963981 | VYGON BIONECTOR WITH EXTENSION SET Vygon Corp., Feb 14, 1997 |