Baxter Automated Peritoneal Dialysis System Electrical Safety Testing Failure
Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.
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 medical device recall with no reported hospitalizations, illnesses, or injuries. Per the rubric, theoretical hazards without documented harm score no higher than High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems. The recall was initiated because electrical safety testing was not properly performed on the impacted devices and additional testing is required.
The affected devices were distributed in the United States to Alabama, Arkansas, Arizona, Florida, Illinois, North Dakota, New York, Ohio, Texas, and Washington. The recalled units can be identified by serial numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, and 2203109603.
Patients using affected devices should contact Baxter Healthcare Corporation or their healthcare provider for further instructions regarding this recall.
The recalled product
- Product
- Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 16
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 (18)
- Product Code: 5C6M40
- UDI/DI: 0085412676463
- Serial Numbers: 2010013403
- 2102050403
- 2103016303
- 2103061703
- 2104009103
- 2105007803
- 2105022503
- 2110006603
- 2110034803
- 2111034103
- 2202044303
- 2203059903
- 2203071803
- 2203073003
- 2204078503
- 2203109603.
Distribution
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