The Recall Desk
ModerateFDA (Devices)·Z-2472-2015·Announced 2015-09-02

Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a labeling revision to add safety instructions and warnings, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Baxter Healthcare Corp. is recalling 1,213,833 units of the MiniCap Extended Life PD Transfer Set (6") with Twist Clamp, Product Code 5C4482. The recall covers all lots of the product, which is intended for use with Baxter Locking titanium adapters for peritoneal dialysis catheters in disconnect and cycler applications.

The recall is a labeling revision to add instructions for the use of peritoneal dialysis transfer sets. The updated labeling includes instructions for sanitizing the connection, monitoring thyroid function by healthcare providers, caution against reuse or reprocessing of the devices, a warning against use if tip protectors are not in place, and an advisement that the product does not contain natural rubber latex.

The product was distributed worldwide, including nationwide in the United States and in numerous foreign countries. Consumers and healthcare providers should stop using the affected transfer sets and contact Baxter Healthcare or their healthcare provider for instructions on how to proceed.

The recalled product

Product
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are perf
Affected units
1,213,833

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 (2)

  • Product Code: 5C4482
  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →