Do Not Use Certain Saline and Sterile Water Medical Products (2024)

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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 NamePart NumberDescriptionUDI
NURSE ASSIST6492775100ML STERILE SALINE BOTTLEB15064927754G
NURSE ASSIST6492776100ML STERILE WATER BOTTLEB15064927764H
NURSE ASSIST101010CC PREFILLED SYRINGES+B15010104L
NURSE ASSIST5163810CC PREFILLED SYRINGES+B150516384%
NURSE ASSIST1210-BP10ML IV FLUSH SYRINGE+B1501210BP4G
NURSE ASSIST649672330CC PREFILLED SYRINGEB15064967234D
NURSE ASSIST5233330CC PREFILLED SYRINGES+B150523334Z
NURSE ASSIST1203-BP3ML IV FLUSH SYRINGE+B1501203BP4I
NURSE ASSIST1205-BP5ML IV FLUSH SYRINGE+B150120BP4K
NURSE ASSIST6496722SYRINGE PREFILLED 10 MLB15064967224C
NURSE ASSIST1030USP STERILE WATER SYRINGE+B15010304N
NURSE ASSIST1030AUSP STERILE WATER SYRINGE+B1501030A4X
STERICARE62811000ML STERILE SALINE BOTTLE(01)10850421008843
STERICARE62911000ML STERILE WATER BOTTLE(01)10850421008799
STERICARE6240100ML STERILE SALINE BOTTLE(01)10850421008812
STERICARE6250100ML STERILE WATER BOTTLE(01)10850421008768
STERICARE6220120ML STERILE SALINE FOIL LID CUP(01)10850421008874
STERICARE6210120ML STERILE WATER FIOL LID CUP(01)10850421008867
STERICARE6507210ML SALINE WOUND FLUSH(01)10850421008744
STERICARE6270250ML STERILE SALINE BOTTLE(01)10850421008829
STERICARE6260250ML STERILE WATER BOTTLE(01)10850421008775
STERICARE5280500ML STERILE SALINE BOTTLE850421008907
STERICARE6280500ML STERILE SALINE BOTTLE(01)10850421008836
STERICARE5290500ML STERILE WATER BOTTLE850421008914
STERICARE6290500ML STERILE WATER BOTTLE(01)10850421008782
STERICARE650390ML USP SALINE WOULD FLUSH(01)10850421008751
CARDINAL1020100ML STERILE SALINE BOTTLE(01)50192253044490
CARDINAL1022100ML STERILE SALINE BOTTLE(01)50192253044506
CARDINALPT00103427100ML STERILE SALINE BOTTLE(01)50192253044506
CARDINAL1024100ML STERILE WATER BOTTLE(01)50192253044513
CARDINAL10000100ML STERILE WATER BOTTLE(01)50192253044520
CARDINALPT00103419100ML STERILE WATER BOTTLE(01)50192253044513
COVIDIEN210SALSTERILE WOUND SOLUTION(01)10884521139756
COVIDIEN90SALSTERILE WOUND SOLUTION(01)20884521140940
HALYARD OWENS MINORSS0030.9% USP SODIUM CHLORIDE INJECTION(01)20885632389778
HALYARD OWENS MINORSS0050.9% USP SODIUM CHLORIDE INJECTION(01)20885632389761
HALYARD OWENS MINORSS0100.9% USP SODIUM CHLORIDE INJECTION(01)20885632389754
HALYARD OWENS MINOR491541000ML STERILE SALINE BOTTLE(01)20885632395939
HALYARD OWENS MINOR491501000ML STERILE WATER BOTTLE(01)20885632395892
HALYARD OWENS MINOR49155100ML STERILE SALINE BOTTLE(01)20885632395946
HALYARD OWENS MINOR49151100ML STERILE WATER BOTTLE(01)20885632395908
HALYARD OWENS MINORSS010SFR10ML SYRINGE STERILE(01)20885632389846
HALYARD OWENS MINOR49152250ML STERILE SALINE BOTTLE(01)20885632395915
HALYARD OWENS MINOR49148250ML STERILE WATER BOTTLE(01)20885632395878
HALYARD OWENS MINOR49153500ML STERILE SALINE BOTTLE(01)20885632395922
HALYARD OWENS MINOR49149500ML STERILE WATER BOTTLE(01)20885632395885
IDEXX98-09444-01BOTTLE STERILE WATER 10 PACKNo UDI
MAC MEDICAL921010ML FILL SYRINGE LABEL20850020865042
MCKESSON37-62811000ML STERILE SALINE BOTTLE612479228399
MCKESSON37-62911000ML STERILE WATER BOTTLE612479228405
MCKESSON37-6240100ML STERILE SALINE BOTTLE612479168565
MCKESSON37-6250100ML STERILE WATER BOTTLE612479168572
MCKESSON37-6220120ML STERILE SALINE CUP612479168558
MCKESSON37-6210120ML STERILE WATER CUP612479168541
MCKESSON37-6507210ML SALINE WOUND FLUSH612479133761
MCKESSON37-6270250ML STERILE SALINE BOTTLE612479168596
MCKESSON37-6260250ML STERILE WATER BOTTLE612479168589
MCKESSON37-6280500ML STERILE SALINE BOTTLE612479180307
MCKESSON37-6290500ML STERILE WATER BOTTLE612479180314
MCKESSON37-650388.7ML SALINE WOUND FLUSH STERILE612479228429
MEDICHOICE OWENS MINORSWF071CAN STERILE SALINE SPRY MEDI 7.1 OZ(01)50885632127043
MEDLINEDYND1000MLS1000ML STERILE SALINE BOTTLE(01)208882776699466
MEDLINE52011100ML STERILE SALINE BOTTLECustomer Kitted
MEDLINERDI30296100ML STERILE SALINE BOTTLE(01)40884389338248
MEDLINE54380100ML STERILE WATER BOTTLECustomer Kitted
MEDLINERDI30295100ML STERILE WATER BOTTLE(01)40884389338231
MEDLINEEMZ1009124010ML IV FLUSH STERILE FIELD(01)20363807109166
MEDLINEDYND40540110ML STERILE SALINE CUP(01)40884389334233
MEDLINEDYND40570110ML STERILE WATER CUP(01)40884389334226
MEDLINEPCS1650250ML STERILE SALINE BOTTLE(01)40884389338262
MEDLINEPCS1550250ML STERILE WATER BOTTLE(01)40080196427056
MEDLINEDYND500MLS500ML STERILE SALINE BOTTLE(01)40884389118406
MEDLINEDYND500MLW500ML STERILE WATER BOTTLE(01)40884389118390
MEDLINECURSALINE7CAN SALINE STERILE SPRAY CURAD40080196297970
SOLPFF0010.9% SODIUM CHLORIDE IV FLUSH SYRINGE(01)20810062438895
TRUDELLT167007CUP STERILE SALINE FOIL LID 120 MLNo UDI
TRUDELLT167005CUP STERILE WATER FOIL LID 120 MLNo UDI
VYAIRE4873CCUP STERILE SALINE FOIL LID 120 MLDiscontinued

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 FirmDescriptionAdditional Information
Cardinal HealthCovidien 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 DisposalsMedical 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 LLCRegard 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 SolutionsConvenience 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, LLCExpress 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, IncMIC* 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, LPMedline 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.

Do Not Use Certain Saline and Sterile Water Medical Products (2024)

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