Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2

FDA device recall Z-1010-2015 · posted 2015-01-26 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Potential for failure of the pouch packaging seal at high altitudes.

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

OCX

Quantity affected

26,028 units

Distribution

US Distribution.

Date initiated

2015-01-14

Date posted

2015-01-26

Date terminated

2017-04-10

Location

Deerfield, IL

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