Z-1010-2015Class II

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate...

Name: Z-1010-2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate...
Creator: Baxter Healthcare Corp.
Published: 2015-01-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-01-14 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m) on 2015-01-14. FDA classified it as Class II and gives the reason as "Potential for failure of the pouch packaging seal at high altitudes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1010-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-14
Posted: 2015-01-26
Terminated: 2017-04-10
Recalling firm: Baxter Healthcare Corporation
Product: Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Product code: OCX Endoscopic Irrigation/Suction System
Reason for recall: Potential for failure of the pouch packaging seal at high altitudes.
Root cause tag: packaging
FDA root cause: 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 [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.
Quantity in commerce: 26,028 units
Distribution: US Distribution.
Product codes and lots: Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-26

Product code OCX

K960787Class IITur,arthroscopic,cystoscopy Irrigation SetsBaxter Healthcare Corp / cleared 1996-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)