MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Recall
- Recall Number
- Z-1269-2015
- Event Number
- 70512
- Firm
- Baxter Healthcare Corp.
- FEI Number
- 1417572
- Product Code
- KDI
- Status
- Completed
- Root Cause
- Under Investigation by firm
- Initiated
- January 22, 2015
- Posted
- March 13, 2015
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Product may have separating or protruding sponges
Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. If you received your product directly from Baxter, please complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 1. If you ordered product from a dealer, wholesaler, or distributor/reseller, please follow your supplier's reply and recall process. 2. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 3. Contact Baxter Healthcare Center for Service to arrange for return and credit.Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your ship-to account number ready when calling. 4. Please do not return the Baxter customer reply form to Baxter. Reply forms should be returned to your supplier. For clinical questions, contact Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time. For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
4,391,520 units