Baxter Peritoneal Dialysis Transfer Set: Female Connector Separation Risk
Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.
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 with reported mechanical defects (female connector separation). While no illnesses or injuries have been reported in the source, peritoneal dialysis is a life-critical treatment, and connector failure poses a risk-of-harm to patients.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number R5C4483) used in peritoneal dialysis. The device is classified as a Class II medical device.
An increase in complaints has been reported regarding separation of the female connector from the main body of the transfer set. This mechanical failure poses a risk to patients relying on this equipment for dialysis treatment.
Approximately 8,394 units have been distributed worldwide under Lot/Serial Number H23J30067 (UDI/DI 00085412008783). Peritoneal dialysis patients may be affected.
Patients should contact their healthcare provider immediately if they experience or suspect a separated connector. Do not use any transfer set with a separated connector, and consult with your medical team about replacement options.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 8,394
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 00085412008783
- Lot/Serial Numbers: H23J30067
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.
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See all →- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
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