Recall Z-1556-2022 ยท KRA Catheter, Continuous Flush
Micro Therapeutics, Inc.
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
| Date | Jun 30, 2022 |
| Status | Open, Classified |
| Reason | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| Root cause | Under Investigation by firm |
| Action | On June 30, 2022, Micro Therapeutics, Inc. issued a "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to affected customers. The recall notification ask consignees to take the following actions: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Custom |
| Quantity | 8 units |
| Distribution | US Nationwide Distribution: None OUS: Brazil |
| FDA record | Open on fda.gov |