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
Recall
- Recall Number
- Z-3049-2011
- Event Number
- 59466
- Firm
- Churchill Medical Systems, Inc.
- FEI Number
- 1000120555
- Product Code
- LRS
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- July 15, 2011
- Posted
- August 22, 2011
- Terminated
- March 27, 2013
- Address
- 87 Venture Drive, Dover, NH, 03820-5914
Description
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
Outer Kit labeled expiration date longer than the expiration of the shortest expired product
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 returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com
Nationwide Distribution
130,750 units