Gore DrySeal Flex Introducer Sheath Recalled for Incorrect Size Labeling
W. L. Gore & Associates is recalling 141 Gore DrySeal Flex Introducer Sheaths because 16Fr devices were mislabeled as 14Fr.
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: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect size) which fits the rubric criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
W. L. Gore & Associates, Inc. is recalling 141 units of the Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The recall was initiated because the devices were mislabeled with the incorrect product size, specifically resulting in 16Fr devices being labeled as 14Fr devices.
The affected devices were distributed exclusively to foreign markets in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the United Kingdom. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and distributors in the affected countries should stop using the identified devices and follow the instructions provided by W. L. Gore & Associates, Inc. for return or disposal. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
- Manufacturer
- W. L. Gore & Associates Inc.
- Hazard
- Affected units
- 141
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 (20)
- Serial numbers 21077298
- 21077364
- 21077365
- 21077366
- 21077631
- 21077350
- 21077351
- 21077414
- 21060888
- 21077339
- 21077340
- 21077341
- 21077417
- 21077418
- 21061626
- 21077286
- 21077336
- 21077337
- 21077211
- 21077304
Distribution
Distribution scope not specified by the agency.
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