Recall Z-3049-2011 ยท LRS I.V. Start Kit
Churchill Medical Systems, Inc.
Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
| Date | Aug 22, 2011 (initiated Jul 15, 2011) |
| Status | Terminated |
| Reason | Outer Kit labeled expiration date longer than the expiration of the shortest expired product |
| Root cause | Employee error |
| Action | Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and re |
| Quantity | 130,750 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.