GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date
W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.
What this means for you
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: This is an FDA Class II recall for a labeling error on a medical device. The source specifies the hazard as an incorrect expiration date (labeled 3 years instead of 2 years). According to the severity rubric, Class II recalls involving minor labeling errors without reported illnesses or injuries are classified as Moderate (Score 2).
Plain-English summary
W. L. Gore & Associates, Inc. is recalling GORE CARDIOFORM Septal Occluders because the devices are labeled with a 3-year expiration date instead of the correct 2-year expiration date.
The affected devices were distributed throughout the United States and internationally. Affected serial numbers range from 22689696 through 23569078. The GORE CARDIOFORM Septal Occluder is a catheter-based medical device used for septal occlusion procedures.
An incorrect expiration date on a medical device could result in use beyond the device's labeled shelf life. This recall is being conducted to ensure healthcare providers and patients are informed of the labeling discrepancy.
The recalled product
- Product
- REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- incorrect-expiration-date
- labeling-error
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 (1)
- serial numbers 22689696 through 23569078
Distribution
Distributed in 47 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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