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Terminated

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

FDA Recall Z-1409-2020 · Posted None

Recall StatusTerminated
Product CodeKDI
Date Initiated2019-11-15
Date Terminated2020-11-20
Product Quantity101976 devices

Reason for Recall

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

Firm Action

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

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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