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High RiskFDAfda-Z-1149-2024OTHER

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tr...

Units Affected
3,480
Recall Date
January 22, 2024
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1149-2024.

Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1149-2024.

Recall ongoing. Follow firm instructions.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1149-2024.

B. Braun Medical, Inc.

FDA

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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B. Braun Medical, Inc. Recall FAQ

B. Braun Medical, Inc. is the subject of a surgical devices safety report: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tr.... The notice was published on January 22, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 3,480 units are potentially affected.