Baxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
Baxter MiniCap Extended Life PD Transfer Sets may be damaged by certain cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents, potentially causing leaking or cracking. No injuries have been reported.
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 is an FDA Class II device recall with no reported illnesses or injuries. The hazard is theoretical: cleaning products may cause the peritoneal dialysis transfer set to crack or leak. The product poses risk of harm if damaged, but no actual injuries have been reported, placing this in the 'High' category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 23,940 units of the MiniCap Extended Life PD Transfer Set (Easy-Lock), model 5C4449, a medical device used in peritoneal dialysis. The recall affects all lot numbers within expiry and has been distributed worldwide.
Certain cleaning products can damage the transfer sets, specifically causing cracking or leaking. These include products containing hydrogen peroxide, bleach, alcohol, antiseptic agents, and solvents such as acetone, toluene, xylene, or cyclohexanone.
No illnesses or injuries have been reported to date. If you are using one of these affected transfer sets, contact your healthcare provider or Baxter Healthcare Corporation for guidance on replacement options or safe use.
The recalled product
- Product
- Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 23,940
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 (1)
- All lot numbers within expiry
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
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
- ModerateNovo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
Similar recalls
- ModerateBaxter MiniCap Extended Life PD Transfer Set Labeling Recall
FDA (Devices) · 2015-09-02
- SevereBaxter MiniCap PD Transfer Set Recalled for Potential Chemical Exposure Risk
FDA (Devices) · 2024-11-27
- SevereBaxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk
FDA (Devices) · 2024-11-27
- SeverePeritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk
FDA (Devices) · 2024-11-27
- SevereBaxter MiniCap PD Transfer Set Recalled for Potential PCB Exposure
FDA (Devices) · 2024-11-27
- SevereBaxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk
FDA (Devices) · 2024-11-27