Recall Z-2389-2011 ยท LKB Pad, Alcohol, Device Disinfectant
Vygon Corporation
Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing kit.
| Date | Jun 11, 2011 (initiated Apr 19, 2011) |
| Status | Terminated |
| Reason | Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. |
| Root cause | Nonconforming Material/Component |
| Action | A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle prod |
| Quantity | 4,000 units |
| Distribution | United States (FL, MA, MD, and VA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.