The Recall Desk
HighFDA (Devices)·Z-0576-2022·Announced 2022-02-16

Baxter PD Transfer Set Recall: Risk of Leaking or Cracking

Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.

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: FDA Class II medical device with potential for serious harm if materials are damaged, classified as a risk-of-harm product where injury has not yet been reported. No reported illnesses or injuries; the hazard is conditional on exposure to specific cleaning products.

Plain-English summary

Baxter Healthcare Corporation is recalling 62,712 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp (REF R5C4482E) distributed worldwide. The recall was initiated because certain cleaning products may damage the transfer sets. Specifically, products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or solvents such as acetone, toluene, xylene, or cyclohexanone may cause the transfer sets to leak or crack.

All lot numbers within their expiry dates are included in the recall.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
  • material-incompatibility
  • device-leakage
  • device-cracking

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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