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FDA Alert: FDA Safety Communication: Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist

February 6, 2024

Audience: Consumers, Health Care Providers, Health Care Facilities

Update: February 6, 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 described below.

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 2/6/2024):

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. ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility | FDA; 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
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

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.

Content current as of: February 6, 2024

Source: FDA

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