Recall Z-1556-2022— Micro Therapeutics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Micro Therapeutics, Inc., initiated 2022-06-30. It names 2 FDA 510(k) clearances: K093750, K030688. Product: Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only. Reason: Outer carton packaging of microcatheters were exposed to wet substance during transport..
- Recalling firm
- Micro Therapeutics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-30
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K093750 — ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
- K030688 — ECHELON MICRO CATHETER, MODEL 105-5092-150
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Reason for recall
Outer carton packaging of microcatheters were exposed to wet substance during transport.
Data sourced from openFDA. This site is unofficial and independent of the FDA.