Stryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters
Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (mislabeled for size). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Stryker Sustainability Solutions is voluntarily recalling 18 units of reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters. The affected devices, identified by catalog numbers 401450 and 401877, were distributed in New York and Canada. The recall was initiated because the devices were mislabeled for size.
These catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The specific lots involved are 2561683E (expiration date 5/13/2017) and 2555866E (expiration date 5/6/2017). The recall was initiated on April 28, 2016, and was terminated on June 29, 2016.
The FDA classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The recall was initiated by the firm and notified via letter.
The recalled product
- Product
- Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 18
Distribution
Distributed in 1 state:
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