Z-0486-2018 Class II Terminated
FDA device recall Z-0486-2018 was initiated by Arrow International Inc on July 10, 2017 and is designated Class II. Reason for recall: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification. The recall status is terminated (terminated September 14, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- July 10, 2017
- Termination Date
- September 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Reason for Recall
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Distribution Pattern
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Code Information
Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547