Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the FDA applies to medical devices that can be expected to cause serious injury or death. FDA Class I recalls are scored as Critical per the severity rubric.
Plain-English summary
Baxter Healthcare Corporation has issued a Class I recall of 1,240 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short (Part Number T5C4484), a device used in peritoneal dialysis treatment. The recall addresses a potential risk of exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) and polychlorinated biphenyls (PCBs).
Baxter became aware of this potential hazard through recalls by other medical device manufacturers for similar peritoneal dialysis and hemodialysis devices. The affected units carry UDI/DI 00085412008783 with lot/serial numbers H20B11074 and all subsequent production lots. These devices were distributed worldwide, including throughout the United States.
The FDA classified this as a Class I recall, the agency's highest severity classification for medical device recalls.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,240
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 (2)
- UDI/DI 00085412008783
- Lot/Serial Numbers: All lots including and manufactured after H20B11074
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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.
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