Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
What this means for you
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 recall for a peritoneal dialysis equipment defect with no reported illnesses, injuries, or hospitalizations. This is a risk-of-harm product where connector separation presents potential for device malfunction, but actual patient harm has not been documented in the source.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K, used in peritoneal dialysis. Approximately 13,376 units were distributed worldwide. Affected lot numbers are H23J02025, H23L04043, H23L05057, H23L05073, H24A29041, H24C01061, H24E13061, and H24G15062.
The FDA-classified Class II recall was initiated due to an increase in complaints of the female connector separating from the transfer set's main body. This separation could compromise the integrity of dialysis treatment and the sterile field required for safe patient therapy.
Users of peritoneal dialysis transfer sets with these lot numbers may be affected by this recall.
Patients should immediately stop using affected transfer sets and contact their healthcare provider for replacement equipment. Healthcare facilities should verify their inventory against the recalled lot numbers and remove any affected units from service.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- connector-separation
- device-malfunction
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 (9)
- UDI/DI 0085412150703
- Lot/Serial Numbers: H23J02025
- H23L04043
- H23L05057
- H23L05073
- H24A29041
- H24C01061
- H24E13061
- H24G15062
Distribution
Distribution scope not specified by the agency.
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