Baxter MiniCap PD Transfer Set Recalled for Female Connector Separation
Baxter Healthcare is recalling 1,496 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation. The affected lots should not be used until assessed by Baxter.
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 recall for a functional device defect (connector separation) in a risk-of-harm product (peritoneal dialysis transfer set) with no reported hospitalizations or injuries. The rubric criterion for Severity 3 (High) applies: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,496 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number T5C4482) used in peritoneal dialysis. The recall was initiated due to an increase in complaints regarding separation of the female connector from the main body of the transfer set. The affected product is identified by UDI/DI 04987456422890 with lot numbers H23L06097 and H24A29033.
A female connector separation affects the integrity of the dialysis transfer set. This is classified as an FDA Class II recall.
The affected units were distributed worldwide. Patients and healthcare facilities using these units should identify affected transfer sets by the part number and lot numbers listed above.
For questions about affected units, contact Baxter Healthcare Corporation.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- connector-separation
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 (3)
- UDI/DI 04987456422890
- Lot/Serial Numbers: H23L06097
- H24A29033
Distribution
Distribution scope not specified by the agency.
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