The Recall Desk
HighFDA (Drugs)·D-0653-2025·Announced 2025-09-24

[pending] SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)

Pending LLM rewrite. Source: FDA_DRUG D-0653-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

The recalled product

Product
SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
Brand
SODIUM CHLORIDE FOR IRRIGATION
Manufacturer
B BRAUN MEDICAL INC

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 (4)

  • Lot#: : J4C521
  • J4C516
  • J4C524
  • Exp. : 28FEB2027.

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM CHLORIDE FOR IRRIGATION