Z-1556-2022 Class II Ongoing
FDA device recall Z-1556-2022 was initiated by Micro Therapeutics, Inc. on June 30, 2022 and is designated Class II. Reason for recall: Outer carton packaging of microcatheters were exposed to wet substance during transport. The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2022
- Initiation Date
- June 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
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.
Distribution Pattern
US Nationwide Distribution: None OUS: Brazil
Code Information
Lot # B177543 UDI: (00) 847536006270