PlainRecalls
FDA Devices Moderate Class II Terminated

HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens

Reported: February 22, 2017 Initiated: January 18, 2017 #Z-1196-2017

Product Description

HARVEST NEEDLE 15GA X 2 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.

Details

Units Affected
15 boxes
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens. Recalled by Argon Medical Devices, Inc. Units affected: 15 boxes.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1196-2017.