Z-0515-2024Class I

Sterile Water: Product Name/

Name: Z-0515-2024 Sterile Water: Product Name/
Creator: Nurse Assist, LLC
Published: 2023-11-06
License: https://open.fda.gov/license/

Nurse Assist, LLC / initiated 2023-11-06 / Open, Classified / root cause: manufacturing process

FDA source

Nurse Assist, LLC began a recall of Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER... on 2023-11-06. FDA classified it as Class I and gives the reason as "Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0515-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2023-12-20
Recalling firm: Nurse Assist, LLC
Product: Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
Product code: EZL Catheter, Retention Type, Balloon
Reason for recall: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/6/23, the firm issued a press release. On 11/09/23, "URGENT: MEDICAL DEVICE RECALL" notices and response forms were emailed and mailed to direct customers and distributors, who were provided with a separate customer recall notice they could forward to their customers. Customers were asked to do the following: 1) Quarantine and then return affected devices. 2) If affected products were further distributed, send these customers the attached recall notice that asks customers to return affected devices to their distributors. 3) Distributors are asked to follow up with customers to ensure they received the recall notification and are taking appropriate action. 4) Distributors are asked to provide their Customer Shipment Report that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, Part Number, Lot Number, and Quantity. This information is important to determine removal effectiveness. 5) Complete and return the response form via email to [email protected] 6) If your company repacked these medical devices into convenience kits, please contact your local FDA recall coordinator to evaluate the need for a new recall. The firm is arranging for removal and replacement of the affected product. The recall notice sent by distributors to their customers also asks that the notice be forwarded to the applicable personnel in their organization or to any organization where the Affected Devices were transferred. Customers with questions can call 800-649-6800, between the hours of 8am and 4:30pm (CST), or email [email protected]
Quantity in commerce: 15,800 Cases
Distribution: US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada
Product codes and lots: Product Code/UDI-DI/Lot: 1030A/B1501030A4/2001155, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 1812001, 22032961, 22114363, 23014570; 6496722/B15064967224/21081990, 22012631, 22012674, 22012712, 22022735, 22012715, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22043126, 22043146, 22043168, 22053339, 22053358, 22053248, 23014630, 23034993, 23035018, 23035017, 23045235; 6496723/B15064967234/22032892, 22032931, 22043213, 22114309, 22114358, 23034943; 1030/B15010304/22032995, 23014586; 51638/B150516384/22033023, 23014632; 52333/B150523334/22033017; 1010/B15010104/22063386, 22063498, 22073735, 23014593

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0511-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20
Z-0512-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20
Z-0513-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20
Z-0514-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20
Z-0515-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20

Product code EZL

K030813Class IIPrimary Care Solutions Prefilled 10Cc and Prefilled 30Cc Inflation Syringes with Sterile Water Catalog Numbers 1010 andPrimary Care Solutions, Inc. / cleared 2003-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)