Z-0502-2012

REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless...

Name: Z-0502-2012 REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless...
Creator: Nurse Assist, Inc
Published: 2011-09-02
License: https://open.fda.gov/license/

Nurse Assist, LLC / initiated 2011-09-02 / Terminated / root cause: design

FDA source

Nurse Assist, Inc began a recall of REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free... on 2011-09-02. The reason FDA records is "Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0502-2012
Status: Terminated
Initiated: 2011-09-02
Posted: 2012-01-11
Terminated: 2012-10-26
Recalling firm: Nurse Assist, LLC
Product: REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs 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 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs
Product code: KOD Catheter, Urological
Reason for recall: Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Root cause tag: design
FDA root cause: Component design/selection
Action: Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.
Quantity in commerce: 7192 cases
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
Product codes and lots: Assembly ID UT70101002U and UT70101400U. Lot Numbers: 905184 (1999116), 905240 (2013784), 905306 (2022227), 906320 (2050130), 906326 (2050141), 907177 (2075692), 907229 (2079816), 909270 (2152734), 910007 (2165988), 910224 (2183856), 911074 (2205933), 912006 (2242897), 912245 (2265322), 1001328 (2299790), 1002197 (2324937), 1002350 (2342704), 1003055 (2346521), 1003163 (2362102), 1003337 (2376018), 1004331 (2412783), 1005322 (2447048), 1006195 (2473260), 1007028 (2494621), 1007132 (2505492), 1007365 (2521813), 1007374 (2521824), 1008200 (2521842), 1008272 (2548567), 1010125 (2609442), 1010211 (2619061), 1010379 (2635683), 1011117 (2653292), 1011242 (2662145), 905179 (1999111), 905304 (2022225), 906031 (2024204), 906034 (2024207), 906223 (2045289), 906317 (2050127), 906322 (2050137), 907174 (2075689), 907224 (2079809), 907410 (2096921), 909321 (2155644), 910002 (2165983), 910217 (2183849), 910315 (2193854), 910405 (2197500), 911071 (2205929), 911272 (2225075),912004 (2242895), 912242 (2265319), 912357 (2270548), 1001032 (2272542), 1001122 (2282233), 1001325 (2299787), 1002031 (2308780), 1002192 (2324932), 1002262 (2332074), 1002348 (2342702), 1003049 (2346515), 1003161 (2362100), 1003276 (2371680), 1003329 (2375786), 1003334 (2376015), 1003340 (2376022), 1004239 (2399012), 1004326 (2412777), 1005001 (2421350), 1005176 (2434535), 1005318 (2447043), 1006068 (2456705), 1006106 (2463036), 1006190 (2473255), 1006315 (2480387), 1007021 (2494612), 1007128 (2505486), 1007363 (2521808), 1007370 (2521819), 1008019 (2521827), 1008195 (2521834), 1009017 (2555280), 1009280 (2592199), 1009383 (2600148), 1010123 (2609440), 1010206 (2619056), 1010377 (2635681), 1011076 (2644159), 1011114 (2653289). Pack Lot #s: 35207, 35317, 35560, 35853, 35995, 36146, 36302, 36467, 36614, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807, 35207 35317, 35560, 35853,35995, 35995-36146, 36146, 36302, 36467, 36614, 36763, 36614, 36614/36763, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807.

Product code KOD

K830359Class IISterile Catherization Procedure TraysWelcon, Inc. / cleared 1983-03-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)