The Recall Desk
HighFDA (Devices)·Z-0578-2022·Announced 2022-02-16

Baxter MiniCap PD Transfer Sets may leak or crack with certain cleaners

Certain cleaning products can damage Baxter MiniCap PD Transfer Sets, potentially causing them to leak or crack. This could affect the safety of peritoneal dialysis treatment if the damaged set is used.

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: This is classified as High because the product is a medical device with potential risk of harm (leaking or cracking) that could affect dialysis treatment safety, though no illnesses or injuries have been reported. The FDA Class II classification supports this assessment.

Plain-English summary

Baxter Healthcare Corporation is recalling 13,590 units of the Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long (REF R5C4484) worldwide. This is a medical device used in peritoneal dialysis, a kidney failure treatment.

The transfer sets may leak or crack if exposed to certain cleaning products, including hydrogen peroxide, bleach, alcohol, antiseptic agents, and solvents such as acetone, toluene, xylene, or cyclohexanone. These are common household and healthcare cleaning products.

Patients and healthcare facilities using these transfer sets should avoid exposure to these cleaning agents. If exposure has occurred, consult your healthcare provider immediately. The FDA has classified this as a Class II recall.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • leaking
  • cracking
  • chemical-damage

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 (1)

  • All lot numbers within expiry

Distribution

Distribution scope not specified by the agency.

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