Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits
Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.
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: The recall is classified as FDA Class II and involves a risk of fluid leaks during dialysis treatment, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits. The recall involves 256 kits that were distributed nationwide. The specific product code is 6997274, and the affected lot codes are 160718E, 160720E, and 160825E.
The recall is due to incorrect silicone straight connector components packaged in the kits. These connectors are larger than expected. During preventive maintenance, these specific connectors must only be installed in the Phoenix mass-balance section of the hydraulic circuit if the machine has already been modified with the "CONN. IMPROVING RETR. KIT" (Code SP00721). If these incorrect connectors are installed in machines modified with SP00721, it may result in fluid leaks during dialysis treatment.
The Phoenix Hemodialysis delivery system is intended for use by trained operators in chronic care dialysis facilities or acute care units for patients weighing 15 kilograms or more. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 256
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 (4)
- Product code: 6997274
- Lot codes: 160718E
- 160720E
- 160825E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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