Recall Z-1236-2020 ยท BSO Catheter, Conduction, Anesthetic
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
| Date | Dec 20, 2019 |
| Status | Terminated |
| Reason | Product lidstock contains the incorrect expiration date for the product |
| Root cause | Incorrect or no expiration date |
| Action | Arrow issued Urgent Medical Device Notification dated 12/20/19 stating reason for recall, health risk and action take: 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex. If an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-396-2111. 4. To return affe |
| Quantity | 250 units |
| Distribution | Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET Teleflex, Inc., Mar 27, 2015 |