The Recall Desk
SevereFDA (Devices)·Z-0512-2024·Announced 2023-12-27

Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure

Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall designation indicates reasonable probability that use could cause serious adverse health consequences. Per classification rules, FDA Class I recalls score at minimum 4 (Severe).

Plain-English summary

Nurse Assist, LLC is recalling 0.9% Sodium Chloride IV flush solutions marketed as 10mL IV FLUSH STERILE FIELD (Product Code EMZ10091240). The recall involves 3,360 cases distributed across the United States, Puerto Rico, and Canada.

The FDA classified this as a Class I recall due to potential loss of sterility assurance. Nonsterile solutions used for intravenous flushing could cause infection.

The following lot numbers are included in the recall: 21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, and 22104234. The product was distributed nationwide and to Canada.

Healthcare providers should immediately discontinue use of affected product and contact the manufacturer for replacement or disposal guidance.

The recalled product

Product
0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
Manufacturer
Nurse Assist, LLC
Hazard
  • lack-of-sterility
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364
  • 21112439
  • 21112455
  • 21122507
  • 21122551
  • 21122576
  • 21122593
  • 21122609
  • 21122617
  • 22012635
  • 22073671
  • 22094119
  • 22104179
  • 22104234

Distribution

Distributed nationwide across the United States.