Z-1194-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- May 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 497 boxes
Product Description
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
Reason for Recall
The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Code Information
lots: 11156986, 11158618, 11158620