Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set due to reports of connector separation that could interrupt dialysis treatment. The recall affects 31,248 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: This Class II medical device recall involves confirmed complaints of functional failure (connector separation) in a critical life-sustaining treatment device. While no injuries or illnesses have been reported, a device malfunction affecting peritoneal dialysis treatment constitutes a risk-of-harm product, meeting the criteria for High severity per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482S) used in peritoneal dialysis treatment. The recall affects 31,248 units distributed worldwide.
The transfer set is being recalled due to an increase in complaints related to the separation of the female connector from the main body of the transfer set. This separation could disrupt peritoneal dialysis treatment.
Patients using peritoneal dialysis should verify whether their transfer sets are from the affected lot numbers: H23J13063, H23J26081, H24B18059, H24B19065, H24B19099, H24B20071, H24C18065, H24E22062, H24F11048.
Patients with affected units should contact their healthcare provider for guidance on continuation of treatment. Additional information is available from the FDA.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 31,248
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 (10)
- UDI/DI 00085412476261
- Lot/Serial Numbers: H23J13063
- H23J26081
- H24B18059
- H24B19065
- H24B19099
- H24B20071
- H24C18065
- H24E22062
- H24F11048
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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- HighBaxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
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- HighBaxter MiniCap PD Transfer Set Recalled for Female Connector Separation
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