Z-1298-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

FDA device recall Z-1298-2018 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: N/A.

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
N/A

Product Description

ArrowClarke" PleuraSeal¿ Thoracentesis Kit

Reason for Recall

Product packaging may not be completely sealed.

Distribution Pattern

Nationally

Code Information

AK01000 AK-01000-J AK-01000-T ASK-01000-CHP