Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with new 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 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 260,244 units of MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp, Product Code 5C4483. 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 was initiated to revise the product labeling. The updated instructions include guidance on sanitizing the connection, monitoring thyroid function, cautioning against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advising 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 product and contact Baxter Healthcare for further instructions regarding the labeling revision.
The recalled product
- Product
- MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and…
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 260,244
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: 5C4483
- 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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