Baxter MiniCap PD Transfer Set Recalled for Connection Leak Risk
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets because connection issues may cause leaks and contamination, potentially leading to peritonitis.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a risk of serious injury (peritonitis) due to contamination, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Baxter Healthcare Corporation is recalling 6,048 units of the MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. The affected product is identified by Product Code 5C4483 and Lot# H12030047. These sterile medical devices were distributed nationwide in the United States and internationally to Canada and Malaysia.
The recall was initiated because connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway. This contamination may result in peritonitis, a serious infection of the abdominal lining.
Patients and healthcare providers using this specific lot of the Baxter MiniCap Extended Life PD Transfer Set should stop using the product and contact their healthcare provider or Baxter Healthcare for further instructions.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 6,048
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)
- Product Code 5C4483
- Lot# H12030047
Distribution
Distributed nationwide across the United States.
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