Nurse Assist, Inc: 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

Recall number

Z-2259-2011

Recalling firm

Nurse Assist, Inc

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

Status

Terminated

Initiated

2011-01-20

Posted

2011-05-25

Terminated

2012-10-25

Reason

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.

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

3120 cases

Distribution

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

FCM

Firm FEI

3002695476

Firm city

Fort Worth

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy