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High RiskFDAfda-Z-0560-2025OTHER

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

Units Affected
22,392
Recall Date
October 23, 2024
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0560-2025.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0560-2025.

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-0560-2025.

Baxter Healthcare Corporation

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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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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Baxter Healthcare Corporation Recall FAQ

Baxter Healthcare Corporation is the subject of a medical devices safety report: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis. The notice was published on October 23, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 22,392 units are potentially affected.