Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.
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 3/5 (High).
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 medical device recall with no reported injuries or hospitalizations. The hazard—female connector separation on peritoneal dialysis equipment—represents a risk of harm to patients, but actual injury has not yet been reported. This meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4484) for use in peritoneal dialysis. The recall involves 3,204 units distributed worldwide.
The FDA has classified this as a Class II recall. The recall is due to an increase in complaints related to separation of the female connector from the main body of the transfer set.
Patients and healthcare providers using this transfer set should contact Baxter Healthcare Corporation. Affected units can be identified using lot number H23J23039 (UDI/DI 00085412050768).
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 3,204
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)
- UDI/DI 00085412050768
- Lot/Serial Numbers: H23J23039
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 recalled by Baxter Healthcare Corporation 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 11 products in this recall →Related recalls
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