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U.S. Department of Health and Human Services

Class 2 Device Recall REVACLEAR 300

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  Class 2 Device Recall REVACLEAR 300 see related information
Date Initiated by Firm May 31, 2019
Create Date July 01, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1908-2019
Recall Event ID 83015
510(K)Number K130039  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product REVACLEAR 300 Dialyzer, Product Code 114745L

Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Code Information UDI 07332414123055 Lot Numbers: C419105401 C419105501 C419105601 C419105701 C419105801 C419105901 C419106001 C419106101 C419106201 C419106301 C419106401 C419106501 C419106601 C419106701 C419106801 C419106901 C419107001 C419107101 C419107201 C419107301 C419107401 C419107501 C419107601 C419107701 C419107801 C419107901 C419108001 C419108101 C419108201 C419108301 C419108401 C419108501 C419108601 C419108701 C419108801 C419108901 C419109001 C419109101 C419109201 C419109301 C419109401 C419109501 C419109601 C419109801 C419110001 C419110101 C419110201 C419110301 C419110401 C419110501 C419110601 C419110701 C419110801 C419111001 C419111101 C419111301 C419111501 C419111601 C419111701 
Recalling Firm/
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Baxter Healthcare Center fr Service
Manufacturer Reason
for Recall
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
FDA Determined
Cause 2
Process control
Action The firm, Baxter, sent an " Urgent Product Recall" letter on 05/31/2019. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product or 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 confirmyour receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. 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. 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 Central Time, Monday through Friday. .
Quantity in Commerce 1249272 units
Distribution US Nationwide Distribution and Internationally to: Canada and Bermuda.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS, INC.