Z-1297-2018 Class II Terminated
FDA device recall Z-1297-2018 was initiated by Arrow International Inc on October 24, 2017 and is designated Class II. Reason for recall: Product packaging may not be completely sealed. The recall status is terminated (terminated April 17, 2020). Affected quantity: 30,577 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- October 24, 2017
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,577 eaches
Product Description
Large Volume Abdominal Paracentesis Kit
Reason for Recall
Product packaging may not be completely sealed.
Distribution Pattern
Nationally
Code Information
AK 00376