Sterile water FDA Alerts
The FDA Alerts below may be specifically about sterile water or relate to a group or class of drugs which include sterile water.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for sterile water
Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
On November 6, 2023, Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.
To date, Nurse Assist, LLC has not received any reports of adverse events for these products.
The product was distributed in the United States and Canada. Recalled Product was distributed from November 1, 2021 to September 18, 2023.
Recalled products include the following products, these products may be packaged inside kits:
Product | Size |
---|---|
0.9% Sodium Chloride Irrigation USP |
100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL 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, 1000mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes |
Expiration dates range from November 1, 2023 to September 18, 2025 for all part numbers, with the exception of part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N), which has an expiration date range from November 1, 2023 to September 18, 2028
Detailed product information is as follows:
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 |
Recalled products may be repackaged into medical device convenience kits.
The potential for a compromised sterile barrier was identified during routine product testing. Further investigations prompted a widening of product scope out of an abundance of caution.
Consumers who have these products should stop using them and contact their distributor or Nurse Assist, LLC for return authorization.
Nurse Assist, LLC is notifying its distributors and customers by electronic communication and letter and is arranging for replacement of all recalled products. Users are being requested to coordinate the return of product with Nurse Assist, LLC.
Consumers with questions may contact the company via telephone at 800-649-6800 Monday through Friday between the hours of 8am and 430pm (cst). Consumers may also contact the company via e-mail at productremovalinfo@nurseassist.com.
Nurse Assist, LLC has notified the FDA of this action.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Source: FDA
Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility
FDA Publish Date:April 13, 2020 Company Announcement Date:January 28, 2018 -- Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.
Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.
The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lot includes the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed Nationwide to wholesale businesses.
Kareway Products, Inc is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.
Consumers with questions regarding this recall can contact the Recall Department at 310-532-0009 or recall@kareway.com available Monday through Fridays from 08:30 am to 05:30 pm (Pacific Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA