Z-2259-2011

Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is...

Name: Z-2259-2011 Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is...
Creator: Nurse Assist, Inc
Published: 2011-01-20
License: https://open.fda.gov/license/

Nurse Assist, LLC / initiated 2011-01-20 / Terminated

FDA source

Nurse Assist, Inc began a recall of Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for... on 2011-01-20. The reason FDA records is "The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2259-2011
Status: Terminated
Initiated: 2011-01-20
Posted: 2011-05-25
Terminated: 2012-10-25
Recalling firm: Nurse Assist, LLC
Product: Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast Irrigation Tray with 60 cc Bulb Syringe Contents 1200 cc graduated drain tray 500 cc graduated container 60 cc bulb syringe Waterproof underpad Alcohol wipe For Rx Only Sterile unless packaged is damaged or opened. Latex Free REF: UT1001 Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are irrigation trays for catheters
Product code: FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Reason for recall: The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
FDA root cause: Other
Action: The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.
Quantity in commerce: 3120 cases
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product codes and lots: Lot Code:1003054, 1004242, 1004330, 809067, 901130, 908268, 910006, 910223, 912153, 1001031, 1002190, 1003048, 1003159, 1003332, 1003338, 1005174, 1005316, 1006066, 1006188, 1007018, 807108, 808201, 812215, 901111, 901204, 902045, 902224, 902311, 903067, 903325, 904348, 905303, 908146, 908343, 909168, 909264, 910214, 911271, 912001, and 912148

Product code FCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)