Nurse Assist, Inc: 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

Recall number

Z-0502-2012

Recalling firm

Nurse Assist, Inc

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

Status

Terminated

Initiated

2011-09-02

Posted

2012-01-11

Terminated

2012-10-26

Reason

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

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

7192 cases

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.

Lot, serial or model codes

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.

510(k) numbers

["K830359"]

PMA numbers

not on file

Product code

KOD

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

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