GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling
GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.
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: This is an FDA Class II labeling error involving incorrect expiration date marking (3 years instead of 2 years). No illnesses, injuries, or hospitalizations have been reported, placing this in the 'minor labeling errors' category per the severity rubric.
Plain-English summary
The GORE CARDIOFORM SEPTAL OCCLUDER 20 mm (model GSXE0020) is subject to recall due to incorrect expiration date labeling. Ninety-five units were labeled with a 3-year expiration date when the correct expiration period is 2 years.
The affected devices were distributed across multiple U.S. states and international locations including Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden. The affected units can be identified by serial numbers 22689696 through 23569078.
W.L. Gore & Associates, Inc. is the recalling manufacturer. Healthcare facilities and medical professionals who have received these devices should verify their device serial numbers against the recall information to determine if they have affected units.
The recalled product
- Product
- REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiac Device
- Hazard
- Affected units
- 95
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
Part of a larger recall action
This product is one of 9 recalled by W L Gore & Associates, Inc. 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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