CLASS I ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Sterile Water: Product Name/Product recalled by Nurse Assist

Nurse Assist is recalling Sterile Water: Product Name, distributed nationwide in the US. The recall was initiated on 6 Nov 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled15,800 Cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0515-2024
FDA event ID: 93434
Recalling firm: Nurse Assist, Haltom City, TX
Classification: Class I
Status: Ongoing
Recall initiated: 6 Nov 2023
FDA classified: 20 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Device type: Syringes & Needles

Timeline

6 Nov 2023	Recall initiated by company
20 Dec 2023	Classified by FDA	+44 days
27 Dec 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 93434

This product is part of a recall event; the main page for the event is Product Name/Product recalled by Nurse Assist.

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023	CLASS I	Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023	CLASS I	Sterile Water/Saline: Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023	CLASS I	Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023	CLASS I	0.9% Sodium Chloride: Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide

More recalls from Nurse Assist

All 6

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Device	CLASS I	0.9% Sodium Chloride: Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023Device	CLASS I	Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023Device	CLASS I	Sterile Water/Saline: Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
27 Dec 2023Device	CLASS I	Product Name/Product recalled by Nurse Assist	Nurse Assist	Sterility	Nationwide
11 Jan 2017Device	CLASS I	Normal Saline Flush 0.9% USP Sodium Chloride Injection recalled	Nurse Assist	Other	Nationwide

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All 1,066

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23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide