Cardiocommand TAPSYSTEM Model 2A Medical Device Recall for Assembly Error
Cardiocommand Inc. is recalling six TAPSYSTEM Model 2A units due to a potential assembly error where the battery wire may be incorrectly connected to the power switch.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates the defect is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Cardiocommand Inc. is recalling six units of the TAPSYSTEM Model 2A (REF 8002A) medical device. The recall is due to a potential assembly error that may result in the battery wire being connected to the ON/OFF power switch incorrectly.
The affected units are identified by serial numbers 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A. These devices were distributed in the United States to the states of Arkansas, New Mexico, Pennsylvania, Texas, and Washington.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that the defect is not likely to cause adverse health consequences. Consumers and healthcare providers should contact Cardiocommand Inc. for instructions on how to resolve the issue with the affected devices.
The recalled product
- Product
- TAPSYSTEM Model 2A, REF 8002A
- Manufacturer
- Cardiocommand Inc.
- Affected units
- 6
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 (6)
- SERIAL NUMBERS: 2197A
- 2196A
- 2198A
- 2199A
- 2200A
- and 2201A
Distribution
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