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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Nurse Assist, LLC: Irrigation Saline and Sterile Water Recalled for Lack of Sterility

Agency Publication Date: December 20, 2023
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Summary

Nurse Assist, LLC is recalling approximately 113,182 cases of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP due to concerns that the products may not be sterile. The recall includes various prefilled syringes, bottles, and cups sold under brands such as Cardinal Health, Halyard, Medline, and McKesson. These products, which were distributed nationwide between late 2021 and late 2023, may contain bacteria or other contaminants that could lead to serious medical complications.

Risk

Using non-sterile irrigation solutions can cause life-threatening infections, especially when used in surgical procedures or for cleaning open wounds. The lack of sterility assurance means the product could introduce harmful bacteria directly into a patient's body.

What You Should Do

  1. Immediately identify if you have any affected products by checking the brand name and product code on the packaging, such as Nurse Assist, Cardinal Health, Halyard, Medline, McKesson, Covidien, or SteriCare.
  2. Locate the lot number on the label and compare it against the extensive list of affected codes, which includes lot ranges starting with 21 (manufactured in 2021), 22 (2022), and 23 (2023).
  3. Stop using all affected 0.9% Sodium Chloride and Sterile Water irrigation products immediately and quarantine them to prevent further use.
  4. If you have used these products and experience signs of an infection, such as redness, swelling, fever, or unusual drainage from a wound, contact a healthcare provider immediately.
  5. Contact Nurse Assist, LLC or the distributor where you purchased the kit to receive specific instructions on returning or disposing of the product.
  6. For further information or to report a problem, contact Nurse Assist, LLC directly or call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

📋Other Action

Potential lack of sterility assurance; products should be removed from use.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 0.9% Sodium Chloride IV Flush Syringe (3mL, 5mL, 10mL)
Model / REF:
1203-BP
1205-BP
1210-BP
9210
PFF001
SS003
SS005
SS010
UPC Codes:
20850020865042
20810062438895
20885632389778
20885632389761
20885632389754
Lot Numbers:
21122520
22032938
22022797
23024788
21112359
21112451
22012672
22073712
23096407
23014656
23035163
23076007
23086264
Product: Sterile Water and Saline Bottles (100mL, 250mL, 500mL, 1000mL)
Model / REF:
1020
1022
1024
10000
49148
49152
49154
37-6240
37-6290
37-6270
37-6281
RDI30296
PCS1550
6240
6270
6290
UPC Codes:
50192253044490
50192253044506
50192253044513
50192253044520
20885632395878
20885632395915
612479168565
612479180314
612479168596
10850421008812
Lot Numbers:
21122619
23076080
22012651
23076031
23076067
22093952
23086378
23096424
23014745
23096475
Product: Saline Wound Flush Spray Can (7.1 oz / 210mL)
Model / REF:
SWF071
37-6507
CURSALINE7
6507
UPC Codes:
50885632127043
40080196297970
10850421008744
Lot Numbers:
22022738
23076008
22043122
23076017
22032903
22043097
22022730
23075987
Product: Sterile Water/Saline Cups with Foil Lids (110mL, 120mL)
Model / REF:
DYND40540
DYND40570
6220
6210
T167005
T167007
UPC Codes:
40884389334233
40884389334226
10850421008874
10850421008867
Lot Numbers:
21112358
23055699
22053264
23055627
22022852
23096441
22063547
23096469
22022859
23045267
Product: USP Sterile Water Syringes (10mL, 30mL)
Model / REF:
1030A
6496722
6496723
1030
51638
52333
1010
UPC Codes:
B1501030A4
B15064967224
B15064967234
B15010304
B150516384
B150523334
B15010104
Lot Numbers:
2001155
23014570
21081990
23045235
22032892
23034943
22033023
22033017
22063386
23014593

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93434
Status: Active
Manufacturer: Nurse Assist, LLC
Sold By: Cardinal Health; Covidien; Halyard Owens Minor; IDEXX; McKesson; Medichoice Owens Minor; Medline; SteriCare; Vyaire
Manufactured In: United States
Units Affected: 5 products (61,740 Cases; 3,360 Cases; 31,850 Cases; 432 Cases; 15,800 Cases)
Distributed To: South Carolina, Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington, Wisconsin, Alaska, Alabama, Arkansas, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Louisiana, Maryland, Michigan, Missouri, Montana, New Hampshire, New Mexico, Oklahoma, Oregon, Puerto Rico, South Dakota, Tennessee, Utah, Virginia, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.