Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
FDA Recall Z-1010-2015 · Posted 2015-01-26
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeOCX
Date Initiated2015-01-14
Date Terminated2017-04-10
Product Quantity26,028 units
Reason for Recall
Potential for failure of the pouch packaging seal at high
altitudes.
Firm 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 [email protected] . 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
Distribution Pattern
US Distribution.
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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