Recall Z-0646-2022 ยท DYB Introducer, Catheter
Oscor Inc.
Destino Twist 14F (also branded as Guidestar 14F)
| Date | Dec 22, 2021 |
| Status | Completed |
| Reason | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. |
| Root cause | Process control |
| Action | Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to recall@Oscor.com. |
| Quantity | 549 units |
| Distribution | Distribution to TN and PA in USA OUS distribution to Czech Republic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH Oscor, Inc., Apr 17, 2014 |