Recall Z-0818-2017 ยท DYB Introducer, Catheter
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
| Date | Oct 5, 2016 |
| Status | Terminated |
| Reason | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Root cause | Nonconforming Material/Component |
| Action | Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2 |
| Quantity | 55 |
| Distribution | Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM |
| FDA record | Open on fda.gov |