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Update: April 15, 2024
Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist
In direct response to the Nurse Assist, LLC recall on November 6, 2023, distributors of Nurse Assist water-based medical products and manufacturers of kits and trays that contain Nurse Assist recalled products are initiating voluntary recalls.
The list of additional recalls and affected products are describedbelow.
The FDA is receiving reports of adverse events associated with use of Nurse Assist products and is further evaluating this information.
Date Issued: November 6, 2023
The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands.
On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile:
- 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes);
- Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).
These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit.
Recommendations for Consumers, Health Care Providers, and Facilities
- Check your supply of saline (0.9% sodium chloride) and sterile water medical products (bottles, spray cans, cups, and prefilled syringes) to find out if you have any of the recalled products at home or in your health care facility’s inventory.
- Do not use these recalled products and follow the recommendations in the company’s recall announcement.
- Be aware that these recalled products may be available as individual units or may be included as part of a kit.
- If you have questions about this recall, contact Nurse Assist, LLC by phone at 800-649-6800 Monday through Friday between the hours of 8:00 am and 4:30 pm (CST) or by e-mail at productremovalinfo@nurseassist.com.
- Report any problems with saline and sterile water medical products by Nurse Assist, LLC to the FDA. See Reporting Problems to the FDA below.
Device Description
Water-based medical products include sterile saline (0.9% sodium chloride) and sterile water medical products used for irrigation or flushing of wounds or medical tubing (such as intravenous (IV) catheters and urinary catheters). Water-based products may also be used for other medical purposes.
Products May Not Be Sterile
Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections.
Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients) or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after they are exposed to contaminated water-based medical products.
To date, the FDA is not aware of reports of adverse events associated with the use of these recalled products.
FDA Actions
The FDA will continue to work with Nurse Assist, LLC to help ensure that the public is notified to stop using the recalled products.
The FDA is monitoring reports of problems with water-based medical products manufactured by Nurse Assist, LLC.
The FDA will continue to keep the public informed if new or additional information becomes available.
Affected Products
Product information provided by the company, including Unique Device Identifier (UDI), is in the table below.
The recalled products have these expiration dates:
- November 1, 2023 - September 18, 2025 (all products, except for 1030A)
- November 1, 2023 - September 18, 2028 (part number 1030A)
Brand Name | Part Number | Description | UDI |
---|---|---|---|
NURSE ASSIST | 6492775 | 100ML STERILE SALINE BOTTLE | B15064927754G |
NURSE ASSIST | 6492776 | 100ML STERILE WATER BOTTLE | B15064927764H |
NURSE ASSIST | 1010 | 10CC PREFILLED SYRINGES | +B15010104L |
NURSE ASSIST | 51638 | 10CC PREFILLED SYRINGES | +B150516384% |
NURSE ASSIST | 1210-BP | 10ML IV FLUSH SYRINGE | +B1501210BP4G |
NURSE ASSIST | 6496723 | 30CC PREFILLED SYRINGE | B15064967234D |
NURSE ASSIST | 52333 | 30CC PREFILLED SYRINGES | +B150523334Z |
NURSE ASSIST | 1203-BP | 3ML IV FLUSH SYRINGE | +B1501203BP4I |
NURSE ASSIST | 1205-BP | 5ML IV FLUSH SYRINGE | +B150120BP4K |
NURSE ASSIST | 6496722 | SYRINGE PREFILLED 10 ML | B15064967224C |
NURSE ASSIST | 1030 | USP STERILE WATER SYRINGE | +B15010304N |
NURSE ASSIST | 1030A | USP STERILE WATER SYRINGE | +B1501030A4X |
STERICARE | 6281 | 1000ML STERILE SALINE BOTTLE | (01)10850421008843 |
STERICARE | 6291 | 1000ML STERILE WATER BOTTLE | (01)10850421008799 |
STERICARE | 6240 | 100ML STERILE SALINE BOTTLE | (01)10850421008812 |
STERICARE | 6250 | 100ML STERILE WATER BOTTLE | (01)10850421008768 |
STERICARE | 6220 | 120ML STERILE SALINE FOIL LID CUP | (01)10850421008874 |
STERICARE | 6210 | 120ML STERILE WATER FIOL LID CUP | (01)10850421008867 |
STERICARE | 6507 | 210ML SALINE WOUND FLUSH | (01)10850421008744 |
STERICARE | 6270 | 250ML STERILE SALINE BOTTLE | (01)10850421008829 |
STERICARE | 6260 | 250ML STERILE WATER BOTTLE | (01)10850421008775 |
STERICARE | 5280 | 500ML STERILE SALINE BOTTLE | 850421008907 |
STERICARE | 6280 | 500ML STERILE SALINE BOTTLE | (01)10850421008836 |
STERICARE | 5290 | 500ML STERILE WATER BOTTLE | 850421008914 |
STERICARE | 6290 | 500ML STERILE WATER BOTTLE | (01)10850421008782 |
STERICARE | 6503 | 90ML USP SALINE WOULD FLUSH | (01)10850421008751 |
CARDINAL | 1020 | 100ML STERILE SALINE BOTTLE | (01)50192253044490 |
CARDINAL | 1022 | 100ML STERILE SALINE BOTTLE | (01)50192253044506 |
CARDINAL | PT00103427 | 100ML STERILE SALINE BOTTLE | (01)50192253044506 |
CARDINAL | 1024 | 100ML STERILE WATER BOTTLE | (01)50192253044513 |
CARDINAL | 10000 | 100ML STERILE WATER BOTTLE | (01)50192253044520 |
CARDINAL | PT00103419 | 100ML STERILE WATER BOTTLE | (01)50192253044513 |
COVIDIEN | 210SAL | STERILE WOUND SOLUTION | (01)10884521139756 |
COVIDIEN | 90SAL | STERILE WOUND SOLUTION | (01)20884521140940 |
HALYARD OWENS MINOR | SS003 | 0.9% USP SODIUM CHLORIDE INJECTION | (01)20885632389778 |
HALYARD OWENS MINOR | SS005 | 0.9% USP SODIUM CHLORIDE INJECTION | (01)20885632389761 |
HALYARD OWENS MINOR | SS010 | 0.9% USP SODIUM CHLORIDE INJECTION | (01)20885632389754 |
HALYARD OWENS MINOR | 49154 | 1000ML STERILE SALINE BOTTLE | (01)20885632395939 |
HALYARD OWENS MINOR | 49150 | 1000ML STERILE WATER BOTTLE | (01)20885632395892 |
HALYARD OWENS MINOR | 49155 | 100ML STERILE SALINE BOTTLE | (01)20885632395946 |
HALYARD OWENS MINOR | 49151 | 100ML STERILE WATER BOTTLE | (01)20885632395908 |
HALYARD OWENS MINOR | SS010SFR | 10ML SYRINGE STERILE | (01)20885632389846 |
HALYARD OWENS MINOR | 49152 | 250ML STERILE SALINE BOTTLE | (01)20885632395915 |
HALYARD OWENS MINOR | 49148 | 250ML STERILE WATER BOTTLE | (01)20885632395878 |
HALYARD OWENS MINOR | 49153 | 500ML STERILE SALINE BOTTLE | (01)20885632395922 |
HALYARD OWENS MINOR | 49149 | 500ML STERILE WATER BOTTLE | (01)20885632395885 |
IDEXX | 98-09444-01 | BOTTLE STERILE WATER 10 PACK | No UDI |
MAC MEDICAL | 9210 | 10ML FILL SYRINGE LABEL | 20850020865042 |
MCKESSON | 37-6281 | 1000ML STERILE SALINE BOTTLE | 612479228399 |
MCKESSON | 37-6291 | 1000ML STERILE WATER BOTTLE | 612479228405 |
MCKESSON | 37-6240 | 100ML STERILE SALINE BOTTLE | 612479168565 |
MCKESSON | 37-6250 | 100ML STERILE WATER BOTTLE | 612479168572 |
MCKESSON | 37-6220 | 120ML STERILE SALINE CUP | 612479168558 |
MCKESSON | 37-6210 | 120ML STERILE WATER CUP | 612479168541 |
MCKESSON | 37-6507 | 210ML SALINE WOUND FLUSH | 612479133761 |
MCKESSON | 37-6270 | 250ML STERILE SALINE BOTTLE | 612479168596 |
MCKESSON | 37-6260 | 250ML STERILE WATER BOTTLE | 612479168589 |
MCKESSON | 37-6280 | 500ML STERILE SALINE BOTTLE | 612479180307 |
MCKESSON | 37-6290 | 500ML STERILE WATER BOTTLE | 612479180314 |
MCKESSON | 37-6503 | 88.7ML SALINE WOUND FLUSH STERILE | 612479228429 |
MEDICHOICE OWENS MINOR | SWF071 | CAN STERILE SALINE SPRY MEDI 7.1 OZ | (01)50885632127043 |
MEDLINE | DYND1000MLS | 1000ML STERILE SALINE BOTTLE | (01)208882776699466 |
MEDLINE | 52011 | 100ML STERILE SALINE BOTTLE | Customer Kitted |
MEDLINE | RDI30296 | 100ML STERILE SALINE BOTTLE | (01)40884389338248 |
MEDLINE | 54380 | 100ML STERILE WATER BOTTLE | Customer Kitted |
MEDLINE | RDI30295 | 100ML STERILE WATER BOTTLE | (01)40884389338231 |
MEDLINE | EMZ10091240 | 10ML IV FLUSH STERILE FIELD | (01)20363807109166 |
MEDLINE | DYND40540 | 110ML STERILE SALINE CUP | (01)40884389334233 |
MEDLINE | DYND40570 | 110ML STERILE WATER CUP | (01)40884389334226 |
MEDLINE | PCS1650 | 250ML STERILE SALINE BOTTLE | (01)40884389338262 |
MEDLINE | PCS1550 | 250ML STERILE WATER BOTTLE | (01)40080196427056 |
MEDLINE | DYND500MLS | 500ML STERILE SALINE BOTTLE | (01)40884389118406 |
MEDLINE | DYND500MLW | 500ML STERILE WATER BOTTLE | (01)40884389118390 |
MEDLINE | CURSALINE7 | CAN SALINE STERILE SPRAY CURAD | 40080196297970 |
SOL | PFF001 | 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE | (01)20810062438895 |
TRUDELL | T167007 | CUP STERILE SALINE FOIL LID 120 ML | No UDI |
TRUDELL | T167005 | CUP STERILE WATER FOIL LID 120 ML | No UDI |
VYAIRE | 4873C | CUP STERILE SALINE FOIL LID 120 ML | Discontinued |
Unique Device Identifier (UDI)
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).
Related Additional Recalls (Updated 4/15/2024):
Recalling Firm | Description | Additional Information |
---|---|---|
Cardinal Health | Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist | Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays Affected Covidien and Cardinal Health brand codes and lot numbers |
Busse Hospital Disposals | Medical device kits and trays, such as, tracheostomy care trays, tracheostomy care sets, and dressing change trays, containing 1 Nurse Assist part 6240, Stericare 100ML Sterile Saline Bottle. | Busse Hospital Disposables Issues Nationwide Recall of Kits/Trays Containing Sterile Water Based Products Under Recall by Nurse Assist |
ROi CPS LLC | Regard Operative Lap P&S Surgical trays or kits which contain irrigation solution component recalled by Nurse Assist. | ; Affected Products UDI and lot numbers |
Windstone Medical Packaging dba Aligned Medical Solutions | Convenience kits, such as low extremity packs, ocular packs, and closure kits which contain the recalled Nurse Assist Sterile Saline, brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle. | Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist |
Maquet Cardiovascular, LLC | Express chest drains, models 4000-100N and 4050-100N, disposable systems prepackaged with 30 mL syringe filled with water-based products recalled by Nurse Assist. | Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist |
Avanos Medical, Inc | MIC* Gastric – Jejunal Feeding Tube Kits. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. | Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall |
Medline Industries, LP | Medline and Centurion branded convenience kits may be used at home by patients, caregivers, and home health providers. Convenience kits may be used in medical settings for surgery or other medical procedures. Recalled kits include, but are not limited to, wound care kits, tracheostomy kits and catheter kits. | Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP |
Reporting Problems to the FDA
If you think you had a problem with these recalled products, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.