Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.
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 involves a potential sterility breach in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables, including catalog numbers CB3434CT, D134401, CB3410CT, and CB3412CT. The recall is due to a potential breach in the sterile packaging, which may have resulted in the product being non-sterile.
The affected lots have expiration dates between March 1, 2018, and October 31, 2018. These cables were distributed in the United States to numerous states, including Michigan, Texas, Tennessee, Indiana, Alabama, Florida, Pennsylvania, Alaska, Wisconsin, Montana, South Carolina, Colorado, California, New Hampshire, North Carolina, New Jersey, Delaware, Arizona, Minnesota, Mississippi, Georgia, the District of Columbia, Iowa, New York, New Mexico, Kansas, Ohio, Oklahoma, South Dakota, Oregon, Nevada, Virginia, Maryland, Washington, and Connecticut. Foreign distribution was limited to California.
Healthcare facilities and consumers should stop using these specific cables immediately. Stryker Sustainability Solutions is the recalling firm responsible for managing this recall.
The recalled product
- Product
- Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The…
- Manufacturer
- Stryker Sustainability Solutions
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Sustainability Solutions 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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