Baxter MiniCap Extended Life PD Transfer Set Labeling Recall
Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 criterion for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets, Product Code 5C4449. 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 include additional instructions for the use of peritoneal dialysis transfer sets. The updated labeling includes instructions for sanitizing the connection, healthcare provider monitoring of thyroid function, cautions against reuse or reprocessing of the devices, warnings against use if tip protectors are not in place, and 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 refer to the updated labeling for these additional safety instructions.
The recalled product
- Product
- MiniCap Extended Life PD Transfer Set. Product Code 5C4449. 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 performed at the transfer…
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 33,474
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: 5C4449
- All Lots
Distribution
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.
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