The Recall Desk
HighFDA (Devices)·Z-0572-2022·Announced 2022-02-16

Baxter MiniCap PD Transfer Sets Recalled Due to Damage from Cleaning Products

Baxter Healthcare is recalling 344,190 units of MiniCap Extended Life PD Transfer Sets worldwide because certain cleaning products may cause the sets to leak or crack, potentially affecting patient dialysis treatment.

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 classification with potential product failure (leaking or cracking) of a critical medical device poses risk of harm. No actual illnesses or injuries have been reported; the hazard is theoretical based on exposure to certain cleaning chemicals.

Plain-English summary

Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Extra Short model, part number 5C4483) globally. The recall affects all lot numbers currently within their expiration dates, totaling approximately 344,190 units.

The transfer sets may be damaged—including leaking or cracking—when exposed to certain cleaning products. These products include those containing hydrogen peroxide, bleach, alcohol, antiseptic agents, or organic solvents such as acetone, toluene, xylene, or cyclohexanone.

Patients using these transfer sets for peritoneal dialysis should avoid cleaning them with products containing these chemicals. If damage occurs, the transfer set should not be used and should be replaced. Patients with questions should contact Baxter Healthcare or their healthcare provider.

The recalled product

Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Peritoneal Dialysis / Transfer Set
Hazard
  • material-incompatibility
  • leaking
  • 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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