Z-2448-2019 Class II Terminated
FDA device recall Z-2448-2019 was initiated by LeMaitre Vascular, Inc. on July 24, 2019 and is designated Class II. Reason for recall: incorrect device size being listed on the impacted device packaging The recall status is terminated (terminated May 11, 2020). Affected quantity: 62 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 24, 2019
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
Product Description
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Reason for Recall
incorrect device size being listed on the impacted device packaging
Distribution Pattern
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Code Information
Lot # OLC1051