CLASS I ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Sterile Water/Saline: Product Name/Product recalled by Nurse Assist
Nurse Assist is recalling Sterile Water/Saline: 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
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-0514-2024
- 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
- Other Medical Devices
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/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
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 AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Code/Lot: T167005/22022859, 22083878, 23055524; T167007/21122503, 22022860, 22083862, 22114365, 23045255, 23045267
Where was it sold?
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
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 93434This 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 |
|---|---|---|---|---|---|
| CLASS I | Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide | |
| CLASS I | Sterile Water: Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide | |
| CLASS I | Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS I | 0.9% Sodium Chloride: Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide |
| Device | CLASS I | Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide |
| Device | CLASS I | Sterile Water: Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide |
| Device | CLASS I | Product Name/Product recalled by Nurse Assist | Nurse Assist | Sterility | Nationwide |
| Device | CLASS I | Normal Saline Flush 0.9% USP Sodium Chloride Injection recalled | Nurse Assist | Other | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |