Baxter Healthcare Corporation Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401
Products Sold
UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401
Baxter Healthcare Corporation is recalling Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L due to There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Recommended Action
Per FDA guidance
The firm initiated the recall by letter on 11/15/2019. The letter requests the following actions be taken: "1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, contact your distributor for return and credit. Please note that the Baxter customer reply form is not applicable in this situation. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the reply form. For further information and support: For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Cent
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026