Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.
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: This is an FDA Class II medical device recall for a connector defect in critical peritoneal dialysis equipment. The defect poses a risk of sterility compromise and contamination, but no illnesses or injuries have been reported, consistent with the rubric criterion for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Baxter Healthcare Corporation is recalling 22,392 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482EJ) worldwide.
The transfer sets are used in peritoneal dialysis treatment. Baxter received an increase in complaints that the female connector can separate from the main body of the transfer set, which could compromise the sterile connection required for safe dialysis.
If you use this product, stop using affected units and contact Baxter Healthcare Corporation immediately. Affected lot numbers are H24C19063, H24G22092, and H24G25061. Consult your healthcare provider about alternative treatment options if you have concerns about your care.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- connector-separation
- contamination-risk
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 (4)
- UDI/DI 00085412489643
- Lot/Serial Numbers: H24C19063
- H24G22092
- H24G25061
Distribution
Distribution scope not specified by the agency.
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