Nurse Assist, LLC
Haltom City, TX, US
NURSE ASSIST, LLC appears in FDA device records in Haltom City, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 64 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Nurse Assist, LLC between 2008 and 2020. The busiest year on record is 2008, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch | NGT | Substantially Equivalent | |
| K150143 | Normal Saline Flush | NGT | Substantially Equivalent | |
| K121390 | LUBE JELLY SURINGE | KMJ | Substantially Equivalent | |
| K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1650927 | 3002695476 | NURSE ASSIST, LLC | 4409 Haltom Rd, Haltom City, TX 76117 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EZLCatheter, Retention Type, Balloon
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- FRODressing, Wound, Drug
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KMJLubricant, Patient
- KMIMonitor, Bed Patient
- NGTSaline, Vascular Access Flush
- KYZSyringe, Irrigating (Non Dental)
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Recall records
Showing 25 of 64| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0515-2024 | Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010 | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | Class I | Open, Classified | |
| Z-0514-2024 | Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007 | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | Class I | Open, Classified | |
| Z-0513-2024 | Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN: STERILE WOUND SOLUTION/90SAL, STERILE WOUND SOLUTION/210SAL; HAYLARD OWENS MINOR: 250ML STERILE WATER BOTTLE/49148, 250ML STERILE SALINE BOTTLE/49152, 1000ML STERILE SALINE BOTTLE/49154, 100ML STERILE SALINE BOTTLE/49155, 1000ML STERILE WATER BOTTLE/49150, 100ML STERILE WATER BOTTLE/49151, 500ML STERILE WATER BOTTLE/49149, 500ML STERILE SALINE BOTTLE/49153; IDEXX: BOTTLE STERILE WATER 10 PACK/98-09444-01; MCKESSON: 100ML STERILE SALINE BOTTLE/37-6240, 500ML STERILE WATER BOTTLE/37-6290, 250ML STERILE SALINE BOTTLE/37-6270, 500ML STERILE SALINE BOTTLE/37-6280, 120ML STERILE WATER CUP/37-6210, 1000ML STERILE SALINE BOTTLE/37-6281, 1000ML STERILE WATER BOTTLE/37-6291, 120ML STERILE SALINE CUP/37-6220, 100ML STERILE WATER BOTTLE/37-6250, 250ML STERILE WATER BOTTLE/37-6260, 210ML SALINE WOUND FLUSH/37-6507, 88.7ML SALINE WOUND FLUSH STERILE/37-6503; MEDICHOICE OWENS MINOR: CAN STERILE SALINE SPRY MEDI 7.1 OZ/SWF071; MEDLINE: 110ML STERILE SALINE CUP/DYND40540, 100ML STERILE SALINE BOTTLE/RDI30296, 250ML STERILE WATER BOTTLE/PCS1550, 250ML STERILE SALINE BOTTLE/PCS1650, 1000ML STERILE SALINE BOTTLE/DYND1000MLS, 100ML STERILE SALINE BOTTLE/52011, 500ML STERILE WATER BOTTLE/DYND500MLW, 500ML STERILE SALINE BOTTLE/DYND500MLS, 100ML STERILE WATER BOTTLE/RDI30295, CAN SALINE STERILE SPRAY CURAD/CURSALINE7, 110ML STERILE WATER CUP/DYND40570, 100ML STERILE WATER BOTTLE/54380; NURSE ASSIST: 100ML STERILE SALINE BOTTLE/6492775, 100ML STERILE WATER BOTTLE/6492776; STERICARE: 90ML USP SALINE WOULD FLUSH/6503, 100ML STERILE SALINE BOTTLE/6240, 100ML STERILE WATER BOTTLE/6250, 250ML STERILE SALINE BOTTLE/6270, 500ML STERILE WATER BOTTLE/6290, 250ML STERILE WATER BOTTLE/6260, 500ML STERILE SALINE BOTTLE/6280, 1000ML STERILE SALINE BOTTLE/6281, 1000ML STERILE WATER BOTTLE/6291, 210ML SALINE WOUND FLUSH/6507, 120ML STERILE SALINE FOIL LID CUP/6220, 120ML STERILE WATER FIOL LID CUP/6210, 500ML STERILE WATER BOTTLE/5290, 500ML STERILE SALINE BOTTLE/5280; VYAIRE: CUP STERILE SALINE FOIL LID 120 ML/4873C | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | Class I | Open, Classified | |
| Z-0512-2024 | 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | Class I | Open, Classified | |
| Z-0511-2024 | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | Class I | Open, Classified | |
| Z-0926-2017 | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush | Potential contamination with B. cepacia. | Class I | Terminated | |
| Z-0505-2012 | REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter 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 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs | 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. | Terminated | ||
| Z-0504-2012 | REF UT8140 Urethal Insertion Tray 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 Urethal Insertion Tray | 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. | Terminated | ||
| Z-0503-2012 | REF UT7030 Catheter Insertion Tray 30cc 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 30cc Pre-Filled Syringe with PVP Swabs | 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. | Terminated | ||
| Z-0502-2012 | 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 | 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. | Terminated | ||
| Z-0501-2012 | WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CATHETER CARE KIT | 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. | Terminated | ||
| Z-0500-2012 | WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL CATHETER KIT (Female) | 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. | Terminated | ||
| Z-0499-2012 | WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch | 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. | Terminated | ||
| Z-0498-2012 | WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe | 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. | Terminated | ||
| Z-0497-2012 | WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe | 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. | Terminated | ||
| Z-0496-2012 | WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe | 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. | Terminated | ||
| Z-0495-2012 | WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Urethral Catheter Tray with Red Rubber Catheter | 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. | Terminated | ||
| Z-0494-2012 | WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Urethral Catheter Tray with Plastic Catheter | 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. | Terminated | ||
| Z-0493-2012 | WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Urethral Catheter Tray without Plastic Catheter | 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. | Terminated | ||
| Z-0492-2012 | McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Foley Catheter Tray without Catheter | 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. | Terminated | ||
| Z-0491-2012 | McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Urethral Catheter Tray with Red Rubber Catheter | 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. | Terminated | ||
| Z-0490-2012 | McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the USA Urethral Catheter Tray with Plastic Catheter | 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. | Terminated | ||
| Z-2290-2011 | Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8155 Urethral Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Intended use: The trays are urological catheter trays. | The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization. | Terminated | ||
| Z-2289-2011 | Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) PVP solution For Rx Only Sterile unless package is damaged or opened. 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 urological catheter trays. | The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization. | Terminated | ||
| Z-2288-2011 | Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT8145 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free 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 urological catheter trays. Intended use: The trays are urological catheter trays. | The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain