Stryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
Stryker is recalling 101 intracardiac ultrasound catheters labeled with incorrect expiration dates, posing risks of sterility breach or component breakdown.
What this means for you
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 risk-of-harm product (sterility breach, component breakdown) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Sustainability Solutions is recalling 101 units of Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters (REF D087031) due to a labeling error. The devices are labeled with a shelf life of two years, but the actual shelf life is one year. The earliest affected product will expire in May 2020.
The affected catheters were distributed in Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Missouri, Pennsylvania, Tennessee, Texas, Virginia, Washington, and West Virginia. No international distribution is reported.
Use of these mislabeled devices may lead to hazards including sterility breach, component breakdown, or delay in treatment. Healthcare providers should stop using the affected units and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 101
Distribution
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