FDA recall Z-0294-2020

Product

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Reason for recall

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Distribution

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Key facts

Status

Terminated

Initiation date

2018-10-16

Report date

2019-11-13

Termination date

2021-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2020