Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions
Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional 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 classified as FDA Class II and involves labeling revisions to add safety instructions and warnings, which aligns with the rubric for moderate severity involving labeling errors or precautionary measures.
Plain-English summary
Baxter Healthcare Corp. is recalling 35,460 units of the CAPD Solution Transfer Set with Locking Connector (Product Code: 5C4160). The recall is being conducted to revise the product labeling to include additional instructions for use. These updates cover the sanitization of the connection, the need for healthcare provider monitoring of thyroid function, and cautions against the reuse or reprocessing of the devices.
The revised labeling also includes a warning against using the product if tip protectors are not in place and an advisement that the product does not contain natural rubber latex. The affected units are 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 Corp. for further instructions regarding the labeling revision.
The recalled product
- Product
- CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 35,460
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: 5C4160
- 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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