Recall Z-1962-2020— W. L. Gore & Associates Inc.
Class II · Terminated
Class II FDA medical device recall by W. L. Gore & Associates Inc., initiated 2019-11-18, terminated 2020-05-13. It names one FDA 510(k) clearance: K160254. 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.. Reason: The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices..
- Recalling firm
- W. L. Gore & Associates Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-18
- Terminated
- 2020-05-13
- Firm location
- Phoenix, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Reason for recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.