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U.S. Department of Health and Human Services

Class 2 Device Recall Four Lead TUR Irrigation Set

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  Class 2 Device Recall Four Lead TUR Irrigation Set see related information
Date Initiated by Firm January 14, 2015
Date Posted January 26, 2015
Recall Status1 Terminated 3 on April 10, 2017
Recall Number Z-1010-2015
Recall Event ID 70102
510(K)Number K960787  
Product Classification endoscopic irrigation/suction system - Product Code OCX
Product Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC
Plastic Containers, Approximate Length 85" (2.2 m)
Code Information Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
224-948-2000
Manufacturer Reason
for Recall		 Potential for failure of the pouch packaging seal at high altitudes.
FDA Determined
Cause 2		 Package design/selection
Action 1. Locate and remove all affected product 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(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing to fca@baxter.com . Returning the Customer Reply Form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. If product was purchased from a distributor: 1. Locate and remove all affected product 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. The 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. 3. Follow your supplier's recall and response process. Please do not return the customer reply form to Baxter.
Quantity in Commerce 26,028 units
Distribution US Distribution.
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 = OCX and Original Applicant = BAXTER HEALTHCARE CORP.
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