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REVACLEAR recallZ-1409-2020 · Baxter Healthcare Corporation · initiated Nov 15, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

FDA root cause category: Process control

What the company is doing

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 [email protected], 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

Recall details

Recall number
Z-1409-2020
Status
Terminated
Initiated by the company
Nov 15, 2019
Recalling firm
Baxter Healthcare Corporation
Quantity
101976 devices
Product code
KDI
FDA submissions
K130039
Distribution
Nationwide

Product description

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Code information (models, lots, serial numbers)

UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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