Recall Z-1962-2020 ยท DYB Introducer, Catheter
W. L. Gore & Associates Inc.
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. |
| Root cause | Labeling Change Control |
| Action | The recalling firm issued Field Safety Notices dated 11/19/2019 with FSN Ref and FSCA Ref numbers of #0000000-11152019-001-R titled "Mislabelled 16Fr Introducer Sheaths Labelled as 14FR (3 lots)" issued via email and overnight mail. Return of the devices was requested. |
| Quantity | 141 devices |
| Distribution | All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160254 | GORE DrySeal Flex Introducer Sheath W. L. Gore & Associates, Inc., May 12, 2016 |