Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected 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: FDA Class II medical device with reported component separation complaints. The source text does not document any injuries or hospitalizations. Per the rubric, this risk-of-harm medical device without reported injury scores as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Extended Life PD Transfer Set with Twist Clamp (Part Number 5C4482) worldwide. Approximately 409,464 units are affected across all distributed lots.
The company has received an increase in complaints related to separation of the female connector from the main body of the transfer set.
The transfer set is used in peritoneal dialysis treatment. Patients currently using this product should contact their healthcare provider immediately regarding the recall. Healthcare facilities should identify affected units by Part Number 5C4482 and affected lot numbers, and remove them from inventory pending replacement.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 409,464
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 (20)
- UDI/DI 00085412007731
- Lot/Serial Numbers: H23J16074
- H23K01082
- H23K06107
- H23K09093
- H23K28051
- H23K30081
- H23L07053
- H23L13051
- H23L27093
- H24A03061
- H24A09035
- H24A11064
- H24A29132
- H24B02038
- H24B12086
- H24B21079
- H24B28090
- H24B29072
- H24B29098
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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Same hazard · connector separation
See all →- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- HighBaxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
FDA (Devices) · 2024-12-04
- HighBaxter Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- HighBaxter MiniCap PD Transfer Set Recalled for Female Connector Separation
FDA (Devices) · 2024-12-04
- HighBaxter Dialysis Transfer Set Recalled for Connector Separation
FDA (Devices) · 2024-12-04
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