Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
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 recall of a sterile medical device with a functional packaging defect that could result in inadequate disinfection. No illnesses or injuries have been reported, but the defect poses a potential risk in a sterile medical procedure.
Plain-English summary
Baxter Healthcare Corporation is recalling the MiniCap Disconnect Cap with Povidone-Iodine Solution (product code 5C4466P), an accessory to administration sets used in peritoneal dialysis. Approximately 33,866,400 units are affected, distributed nationwide in the United States and in Canada.
The MiniCap caps are packaged in foil pouches that may have been incorrectly sealed. Pouches with open or weak seals can allow air exposure, reducing the amount of iodine and drying the sponge inside the cap. This could result in insufficient disinfectant on the cap's surface.
The cap is used to maintain sterility of the dialysis catheter connection. Inadequate disinfection poses a risk of infection for patients undergoing peritoneal dialysis.
Patients and healthcare providers using this product should contact Baxter Healthcare Corporation or their healthcare provider for information about the recall and next steps.
The recalled product
- Product
- Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 33,866,400
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 (9)
- UDI/DI 00085412007694
- Lot numbers: GD912051
- exp 31-Mar-2024
- GD912068
- exp 30-Apr-2024
- GD912099
- GD912112
- GD912143
- GD912204
Distribution
Distributed nationwide across the United States.
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Similar recalls
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