Recall Z-0331-2017 ยท DQO Catheter, Intravascular, Diagnostic
Arrow International Inc
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
| Date | Sep 2, 2016 |
| Status | Terminated |
| Reason | Labeling inconsistency |
| Root cause | Labeling mix-ups |
| Action | Arrow sent an Urgent Medical Device Recall Notification letter dated September 20, 2016, to all affected customers via FedEx 2-day air. The letter identified the problem and provided instructions to immediately discontinue use and quarantine any products with the associated lot numbers indicated in the letter. If product was found, customers were asked to complete the Recall Acknowledgement Form and a Customer Service Rep will issue a Return Goods Authorization (RGA) Number for the product's return. Disposition of recalled product will be scrapped. For further questions, please call (610) |
| Quantity | 330 units in US and 1,031 units OUS |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895268 | ARROW HANDS-OFF THERMO-PACE Arrow Intl., Inc., Nov 6, 1989 |